This document provides a summary of Debra Johnson's experience and qualifications. She has over 20 years of experience in clinical research as a clinical research associate and coordinator. Her most recent role is as a Senior Clinical Research Associate at Harvard Clinical Research Institute in Boston, where she conducts monitoring visits and assists with various clinical trial activities. She has extensive experience in monitoring, site management, and ensuring regulatory compliance.
Wanda Peterson has over 15 years of experience in clinical research as a senior clinical research coordinator and certified clinical study coordinator. She is currently a senior clinical research coordinator at Hometown Urgent Care & Research in Columbus, Ohio, where she is responsible for managing study documentation, data collection, patient training and assessment, maintaining study records, and ensuring compliance with Good Clinical Practice standards. Previously she held similar roles at several clinical research organizations and healthcare facilities in Ohio.
Addie Brooks has over 10 years of experience as a clinical research associate (CRA) leading clinical trials in various therapeutic areas such as oncology, respiratory diseases, infectious diseases, and more. She currently works as a lead CRA at INC Research, where her responsibilities include monitoring clinical trials, ensuring regulatory compliance, and providing guidance to junior CRAs. Previously, she held CRA roles at various CROs such as PPD and RPS, where she gained experience in project management, site monitoring, and training other staff.
Marcie Popovich is seeking a position utilizing her experience in team-based environments and completing tasks. She has over 15 years of experience as a clinical research coordinator and medical assistant. Her background includes initiating and coordinating clinical trials in dermatology and cardiology, ensuring regulatory compliance, recruiting and screening participants, collecting data, and maintaining study documentation. She is proficient in relevant computer systems and holds certifications in first response, CPR, phlebotomy, and EKG administration.
The document provides a curriculum vitae for Siyabonga Excellent Mchunu, including his current position as a Research & Data Coordinator since May 2012. His responsibilities in this role involve coordinating research studies, collecting study documents, obtaining participant consent, screening participants, coordinating tests and procedures, maintaining study timelines and records, and assisting the principal investigator. He also has experience as a Research Assistant from 2011-2012 and Data Capture from 2009-2011 in related roles of screening and booking participants, observing self-tests, entering data, and reporting statistics.
I am writing in regards to the Clinical Research Associate position that is open with your company at this time. I am an experienced CRA with over three years in clinical trials with broad background in clinical trials management of Phase II/III trials in various indications including the implementation of study protocols, monitoring of study sites and on-site data management and collection of study-related documents. With excellent organizational skills and a profound background of working in a managerial capacity, along with my ability to learn rapidly and proficiently, will allow me to be a valuable part of your team as well as contribute to your constant success.
Alexander Baldridge has over 3 years of experience as a Clinical Research Associate and over 5 years of experience in clinical research roles. He currently works as a CRA II at SCRI, where his responsibilities include assisting with investigator selection, developing patient recruitment strategies, performing site monitoring visits, and ensuring compliance. Previously he has held CRA roles at ICON Clinical Research and roles in clinical trial coordination and management. He has experience across multiple therapeutic areas, including oncology trials in lung cancer, leukemia, breast cancer, and molecular profiling.
This document provides a summary of Patrick Jordan's professional experience and education. He has over 15 years of experience in clinical research, including experience as a Clinical Research Associate and Clinical Research Coordinator. He has strong project management, regulatory, and clinical trial experience across various therapeutic areas and phases of drug development. He holds a Bachelor's degree in Business Administration and is a candidate for a Master's degree in Clinical Research.
This document provides a summary of Tatiana B. Lance's professional profile, education, skills, work experience, therapeutic experience, publications, and presentations. She has over 20 years of experience in clinical research and medicine obtained in both Russia and the United States. Her most recent role is as a Central Monitoring Associate for INC Research, where she is responsible for remote monitoring of clinical trials. She aims to obtain a challenging position with a reputable CRO commensurate with her education and experience in bringing new drugs to market and protecting research subjects.
Wanda Peterson has over 15 years of experience in clinical research as a senior clinical research coordinator and certified clinical study coordinator. She is currently a senior clinical research coordinator at Hometown Urgent Care & Research in Columbus, Ohio, where she is responsible for managing study documentation, data collection, patient training and assessment, maintaining study records, and ensuring compliance with Good Clinical Practice standards. Previously she held similar roles at several clinical research organizations and healthcare facilities in Ohio.
Addie Brooks has over 10 years of experience as a clinical research associate (CRA) leading clinical trials in various therapeutic areas such as oncology, respiratory diseases, infectious diseases, and more. She currently works as a lead CRA at INC Research, where her responsibilities include monitoring clinical trials, ensuring regulatory compliance, and providing guidance to junior CRAs. Previously, she held CRA roles at various CROs such as PPD and RPS, where she gained experience in project management, site monitoring, and training other staff.
Marcie Popovich is seeking a position utilizing her experience in team-based environments and completing tasks. She has over 15 years of experience as a clinical research coordinator and medical assistant. Her background includes initiating and coordinating clinical trials in dermatology and cardiology, ensuring regulatory compliance, recruiting and screening participants, collecting data, and maintaining study documentation. She is proficient in relevant computer systems and holds certifications in first response, CPR, phlebotomy, and EKG administration.
The document provides a curriculum vitae for Siyabonga Excellent Mchunu, including his current position as a Research & Data Coordinator since May 2012. His responsibilities in this role involve coordinating research studies, collecting study documents, obtaining participant consent, screening participants, coordinating tests and procedures, maintaining study timelines and records, and assisting the principal investigator. He also has experience as a Research Assistant from 2011-2012 and Data Capture from 2009-2011 in related roles of screening and booking participants, observing self-tests, entering data, and reporting statistics.
I am writing in regards to the Clinical Research Associate position that is open with your company at this time. I am an experienced CRA with over three years in clinical trials with broad background in clinical trials management of Phase II/III trials in various indications including the implementation of study protocols, monitoring of study sites and on-site data management and collection of study-related documents. With excellent organizational skills and a profound background of working in a managerial capacity, along with my ability to learn rapidly and proficiently, will allow me to be a valuable part of your team as well as contribute to your constant success.
Alexander Baldridge has over 3 years of experience as a Clinical Research Associate and over 5 years of experience in clinical research roles. He currently works as a CRA II at SCRI, where his responsibilities include assisting with investigator selection, developing patient recruitment strategies, performing site monitoring visits, and ensuring compliance. Previously he has held CRA roles at ICON Clinical Research and roles in clinical trial coordination and management. He has experience across multiple therapeutic areas, including oncology trials in lung cancer, leukemia, breast cancer, and molecular profiling.
This document provides a summary of Patrick Jordan's professional experience and education. He has over 15 years of experience in clinical research, including experience as a Clinical Research Associate and Clinical Research Coordinator. He has strong project management, regulatory, and clinical trial experience across various therapeutic areas and phases of drug development. He holds a Bachelor's degree in Business Administration and is a candidate for a Master's degree in Clinical Research.
This document provides a summary of Tatiana B. Lance's professional profile, education, skills, work experience, therapeutic experience, publications, and presentations. She has over 20 years of experience in clinical research and medicine obtained in both Russia and the United States. Her most recent role is as a Central Monitoring Associate for INC Research, where she is responsible for remote monitoring of clinical trials. She aims to obtain a challenging position with a reputable CRO commensurate with her education and experience in bringing new drugs to market and protecting research subjects.
This CV summarizes the professional experience of Kory Winkler, BS as a clinical research coordinator from 2006 to present. He has worked at CTI Clinical Research Center since 2011 where he currently serves as a Senior Clinical Research Coordinator. His responsibilities include maintaining knowledge of study protocols, recruiting and consenting participants, coordinating visits and procedures, and ensuring compliance. He previously held similar coordinator roles at Community Research from 2006 to 2011 and technician roles conducting animal research at Battelle Memorial Institute from 2001 to 2006.
The document provides a summary of Donna Harakal's professional experience and qualifications. She has over 15 years of experience as a clinical research nurse and coordinator, leading numerous drug and device studies across various medical disciplines at Northwestern University. Her experience includes recruiting and screening subjects, obtaining consent, supervising data collection, ensuring regulatory compliance, and serving as a liaison between research staff and administrators. She has a Bachelor of Science in Nursing degree and is certified as a clinical research coordinator and psychiatric mental health nurse.
Vijay Kumar is a Site Operations Specialist and Clinical Research Coordinator based in Chandigarh, India. He has over 7 years of experience in clinical research coordination and ensuring compliance and high data quality for clinical trials. His responsibilities include monitoring investigator sites, reviewing study documents, supporting patient recruitment, addressing issues, and ensuring adherence to regulations and good clinical practices. He has experience across various therapeutic areas including cardiology and has participated in both national and international clinical research conferences.
Laura Butler has over 20 years of experience in clinical research. She currently works as a Senior Clinical Research Associate at TFS CRO, where she identifies clinical trial sites, monitors trials, mentors staff, and assists with developing clinical documents. Previously she held similar roles at other clinical research organizations. Butler has a Master's degree in Curriculum and Instruction and speaks English and Spanish fluently.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various hospitals and clinical research organizations where she recruited and consented patients, collected data, tracked regulatory documents, and ensured compliance. Hamm has a Bachelor's degree in Business Administration and is certified as a phlebotomist.
This resume summarizes Michelle O'Neal's objective of obtaining a clinical research position. She has over 25 years of medical administration experience and 7 years of clinical research experience, including pre-clinical through Phase IV studies. She has a proven track record of coordinating investigators, project managers, and regulatory submissions. Her experience includes positions at INC Research, Rho, Research Triangle Institute, Celgene/Abraxis, Quintiles, PPD, and Charles River Laboratories.
Constantine Suvorov is a senior clinical research associate with over 5 years of experience monitoring phase II and III oncology, hematology, gastroenterology, and immunology clinical trials. He has experience monitoring trials in Russia, Central and Eastern Europe, Eastern Asia, and Central Europe. His responsibilities include site initiation, monitoring, source document verification, and site closeout. He is competent in using clinical trial management systems and has experience with various clinical trial vendors.
Kristi Latorre has over 10 years of experience managing clinical trials and research associates. Her current role at PPD involves managing project teams, budgets, and deliverables for clinical trials. Previously she held roles at Covance and Precision Therapeutics as a clinical research associate, where her responsibilities included monitoring clinical sites, ensuring regulatory compliance, and verifying study data. She has extensive experience overseeing all phases of clinical trials from start up through close out.
Stacy H. Flannery has over 15 years of experience in clinical research as an expert study coordinator, clinical trials associate, and clinical research coordinator. She has managed clinical trials through all phases of development across multiple therapeutic areas. She is proficient in various clinical trials databases and systems and ensures compliance with ICH GCP guidelines and regulations.
Cheryl A. Wagner has over 15 years of experience as a clinical research associate and nurse. She received her BSN in 2005 and has worked at PPD since 2006, advancing to the role of Senior CRA where she manages over 60 sites. She has experience in oncology, infectious disease, and women's health clinical trials.
Toni Brown has over 15 years of experience in clinical research, specializing in coordinating, managing, and supporting all phases of clinical trials. She has expertise in areas such as protocol reviews, site management, regulatory documentation, and TMF management. She is proficient in MS Office, clinical trial databases, and has strong communication and organizational skills.
Kathleen Montgomery has over 10 years of experience in clinical research as a research coordinator, clinical research associate, and site assessment specialist. She has a Bachelor's in Genetic Biology and is a certified clinical research professional. She has managed multiple clinical studies across various therapeutic areas and ensured compliance with study protocols and regulations. She has also trained other clinical research professionals and mentored new CRAs.
Evgeniy Bashlakov is an Associate Clinical Operations Leader at PAREXEL International with over 6 years of experience in clinical research. He has managed clinical trials across multiple therapeutic areas involving over 168 patients at 54 sites in 7 countries. Bashlakov also has experience as a physician in general practice, surgery, neurology, and other specialties prior to joining the clinical research industry.
The document is a cover letter and resume submitted by Syed Ameer Basha for a position at an organization. He has over 5 years of experience as a Senior Clinical Research Associate and is seeking a suitable position where he can apply his skills and contribute to the organization's success. His resume details his qualifications and experience in clinical research and bioavailability/bioequivalence studies. He is proficient in GCP guidelines and has experience monitoring clinical trials, collecting and verifying patient data.
Lucinda Fasig is a Clinical Research Associate with over 20 years of experience in clinical research. She has experience monitoring clinical trials to ensure compliance with regulations and guidelines. Her responsibilities include implementing and monitoring trials, qualifying investigative sites, reviewing data for accuracy, and completing required documentation. Previously she has held roles as a Clinical Research Regulatory Specialist, Oncology Clinical Research Coordinator, and Quality Assurance Auditor conducting audits of clinical trials. She has extensive training and is certified as a Clinical Research Coordinator.
The clinical research associate (CRA), also known as the monitor, acts as the main line of communication between the sponsor and investigator. The CRA is responsible for evaluating investigators to ensure they are qualified through training and experience and have adequate resources to properly conduct the trial. Additional responsibilities include conducting pre-study visits to assess investigator experience and facilities, site initiation visits to detail study obligations, and routine monitoring visits to ensure subjects' rights and data accuracy and compliance with regulations. The CRA also performs site closeout visits when enrollment and subjects' activities are complete and data are finalized.
Dr. Prayag N. Shah has over 10 years of experience in clinical research and currently works as General Manager and Head of Global Clinical Regulatory Affairs/Global Medical Affairs at Amneal Pharmaceuticals. He provides strategic and operational support for clinical trials, ensures regulatory compliance, and oversees various functions including project management, medical monitoring, safety reporting and vendor management. He has led several phase II-III trials across therapeutic areas such as cardiology, anti-infectives and obstetrics.
Veronica Rowell has over 15 years of experience in clinical research, primarily focused in oncology, hematology, and cardiology. She has worked as a site manager, clinical research associate, and senior clinical research associate. Her responsibilities have included managing clinical research staff, ensuring protocol compliance, monitoring studies, and analyzing data. She has a Master's degree in Human Services specializing in marriage and family therapy.
sistema web voltado para o gerenciamento de pessoas em seus devidos propósito. Não somos uma empresa, e sim um sistema que gera facilidade aos seus usuários no sentido de gerir doações entre amigos, de livre e espontânea vontade
This document contains the schedule for a Math 4H class over multiple weeks. It lists the day, topic covered, assigned readings from the textbook, and homework for each class period. The class meets in room 429 during periods 3, 4, and 9 and covers topics in chapter 9 of the textbook, including polar coordinates, graphing in polar coordinates, representing complex numbers in polar form, vectors in R^2 and R^3, dot products, and cross products. Quizzes and tests are scheduled to assess student learning of these topics.
Karl Klein is a senior business leader with over 15 years of experience in car rental operations management. He has a proven track record of leading teams to achieve business goals through strategic planning, continuous improvement initiatives, and developing employees. Klein's experience includes roles as an area manager, general manager, operations manager, and location manager for The Hertz Corporation and Dollar Thrifty Automotive Group. He holds a Bachelor of Arts from the University of Michigan - Dearborn and is currently pursuing a Master of Science in Finance from the same institution.
This document contains Kasey Fenton's resume. It outlines her education, including a Master's degree from Grand Canyon University and a Bachelor's degree from Bowling Green State University. It also lists her work experience in insurance claims, substitute teaching, restaurant serving and bartending, teaching 7th grade science and math, and campus tour guiding. It provides her contact information and lists references from past managers and supervisors.
This CV summarizes the professional experience of Kory Winkler, BS as a clinical research coordinator from 2006 to present. He has worked at CTI Clinical Research Center since 2011 where he currently serves as a Senior Clinical Research Coordinator. His responsibilities include maintaining knowledge of study protocols, recruiting and consenting participants, coordinating visits and procedures, and ensuring compliance. He previously held similar coordinator roles at Community Research from 2006 to 2011 and technician roles conducting animal research at Battelle Memorial Institute from 2001 to 2006.
The document provides a summary of Donna Harakal's professional experience and qualifications. She has over 15 years of experience as a clinical research nurse and coordinator, leading numerous drug and device studies across various medical disciplines at Northwestern University. Her experience includes recruiting and screening subjects, obtaining consent, supervising data collection, ensuring regulatory compliance, and serving as a liaison between research staff and administrators. She has a Bachelor of Science in Nursing degree and is certified as a clinical research coordinator and psychiatric mental health nurse.
Vijay Kumar is a Site Operations Specialist and Clinical Research Coordinator based in Chandigarh, India. He has over 7 years of experience in clinical research coordination and ensuring compliance and high data quality for clinical trials. His responsibilities include monitoring investigator sites, reviewing study documents, supporting patient recruitment, addressing issues, and ensuring adherence to regulations and good clinical practices. He has experience across various therapeutic areas including cardiology and has participated in both national and international clinical research conferences.
Laura Butler has over 20 years of experience in clinical research. She currently works as a Senior Clinical Research Associate at TFS CRO, where she identifies clinical trial sites, monitors trials, mentors staff, and assists with developing clinical documents. Previously she held similar roles at other clinical research organizations. Butler has a Master's degree in Curriculum and Instruction and speaks English and Spanish fluently.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various hospitals and clinical research organizations where she recruited and consented patients, collected data, tracked regulatory documents, and ensured compliance. Hamm has a Bachelor's degree in Business Administration and is certified as a phlebotomist.
This resume summarizes Michelle O'Neal's objective of obtaining a clinical research position. She has over 25 years of medical administration experience and 7 years of clinical research experience, including pre-clinical through Phase IV studies. She has a proven track record of coordinating investigators, project managers, and regulatory submissions. Her experience includes positions at INC Research, Rho, Research Triangle Institute, Celgene/Abraxis, Quintiles, PPD, and Charles River Laboratories.
Constantine Suvorov is a senior clinical research associate with over 5 years of experience monitoring phase II and III oncology, hematology, gastroenterology, and immunology clinical trials. He has experience monitoring trials in Russia, Central and Eastern Europe, Eastern Asia, and Central Europe. His responsibilities include site initiation, monitoring, source document verification, and site closeout. He is competent in using clinical trial management systems and has experience with various clinical trial vendors.
Kristi Latorre has over 10 years of experience managing clinical trials and research associates. Her current role at PPD involves managing project teams, budgets, and deliverables for clinical trials. Previously she held roles at Covance and Precision Therapeutics as a clinical research associate, where her responsibilities included monitoring clinical sites, ensuring regulatory compliance, and verifying study data. She has extensive experience overseeing all phases of clinical trials from start up through close out.
Stacy H. Flannery has over 15 years of experience in clinical research as an expert study coordinator, clinical trials associate, and clinical research coordinator. She has managed clinical trials through all phases of development across multiple therapeutic areas. She is proficient in various clinical trials databases and systems and ensures compliance with ICH GCP guidelines and regulations.
Cheryl A. Wagner has over 15 years of experience as a clinical research associate and nurse. She received her BSN in 2005 and has worked at PPD since 2006, advancing to the role of Senior CRA where she manages over 60 sites. She has experience in oncology, infectious disease, and women's health clinical trials.
Toni Brown has over 15 years of experience in clinical research, specializing in coordinating, managing, and supporting all phases of clinical trials. She has expertise in areas such as protocol reviews, site management, regulatory documentation, and TMF management. She is proficient in MS Office, clinical trial databases, and has strong communication and organizational skills.
Kathleen Montgomery has over 10 years of experience in clinical research as a research coordinator, clinical research associate, and site assessment specialist. She has a Bachelor's in Genetic Biology and is a certified clinical research professional. She has managed multiple clinical studies across various therapeutic areas and ensured compliance with study protocols and regulations. She has also trained other clinical research professionals and mentored new CRAs.
Evgeniy Bashlakov is an Associate Clinical Operations Leader at PAREXEL International with over 6 years of experience in clinical research. He has managed clinical trials across multiple therapeutic areas involving over 168 patients at 54 sites in 7 countries. Bashlakov also has experience as a physician in general practice, surgery, neurology, and other specialties prior to joining the clinical research industry.
The document is a cover letter and resume submitted by Syed Ameer Basha for a position at an organization. He has over 5 years of experience as a Senior Clinical Research Associate and is seeking a suitable position where he can apply his skills and contribute to the organization's success. His resume details his qualifications and experience in clinical research and bioavailability/bioequivalence studies. He is proficient in GCP guidelines and has experience monitoring clinical trials, collecting and verifying patient data.
Lucinda Fasig is a Clinical Research Associate with over 20 years of experience in clinical research. She has experience monitoring clinical trials to ensure compliance with regulations and guidelines. Her responsibilities include implementing and monitoring trials, qualifying investigative sites, reviewing data for accuracy, and completing required documentation. Previously she has held roles as a Clinical Research Regulatory Specialist, Oncology Clinical Research Coordinator, and Quality Assurance Auditor conducting audits of clinical trials. She has extensive training and is certified as a Clinical Research Coordinator.
The clinical research associate (CRA), also known as the monitor, acts as the main line of communication between the sponsor and investigator. The CRA is responsible for evaluating investigators to ensure they are qualified through training and experience and have adequate resources to properly conduct the trial. Additional responsibilities include conducting pre-study visits to assess investigator experience and facilities, site initiation visits to detail study obligations, and routine monitoring visits to ensure subjects' rights and data accuracy and compliance with regulations. The CRA also performs site closeout visits when enrollment and subjects' activities are complete and data are finalized.
Dr. Prayag N. Shah has over 10 years of experience in clinical research and currently works as General Manager and Head of Global Clinical Regulatory Affairs/Global Medical Affairs at Amneal Pharmaceuticals. He provides strategic and operational support for clinical trials, ensures regulatory compliance, and oversees various functions including project management, medical monitoring, safety reporting and vendor management. He has led several phase II-III trials across therapeutic areas such as cardiology, anti-infectives and obstetrics.
Veronica Rowell has over 15 years of experience in clinical research, primarily focused in oncology, hematology, and cardiology. She has worked as a site manager, clinical research associate, and senior clinical research associate. Her responsibilities have included managing clinical research staff, ensuring protocol compliance, monitoring studies, and analyzing data. She has a Master's degree in Human Services specializing in marriage and family therapy.
sistema web voltado para o gerenciamento de pessoas em seus devidos propósito. Não somos uma empresa, e sim um sistema que gera facilidade aos seus usuários no sentido de gerir doações entre amigos, de livre e espontânea vontade
This document contains the schedule for a Math 4H class over multiple weeks. It lists the day, topic covered, assigned readings from the textbook, and homework for each class period. The class meets in room 429 during periods 3, 4, and 9 and covers topics in chapter 9 of the textbook, including polar coordinates, graphing in polar coordinates, representing complex numbers in polar form, vectors in R^2 and R^3, dot products, and cross products. Quizzes and tests are scheduled to assess student learning of these topics.
Karl Klein is a senior business leader with over 15 years of experience in car rental operations management. He has a proven track record of leading teams to achieve business goals through strategic planning, continuous improvement initiatives, and developing employees. Klein's experience includes roles as an area manager, general manager, operations manager, and location manager for The Hertz Corporation and Dollar Thrifty Automotive Group. He holds a Bachelor of Arts from the University of Michigan - Dearborn and is currently pursuing a Master of Science in Finance from the same institution.
This document contains Kasey Fenton's resume. It outlines her education, including a Master's degree from Grand Canyon University and a Bachelor's degree from Bowling Green State University. It also lists her work experience in insurance claims, substitute teaching, restaurant serving and bartending, teaching 7th grade science and math, and campus tour guiding. It provides her contact information and lists references from past managers and supervisors.
Scrum is an agile framework for completing complex projects. It focuses on delivering the highest business value in the shortest time. The document discusses the history and principles of Scrum, including its three core values: transparency, adaptation, and inspection. It describes the three roles in Scrum - Product Owner, Scrum Master, and Scrum Team. The Scrum process includes sprints, daily stand-up meetings, sprint reviews, and retrospectives. The key artifacts are the product backlog, sprint backlog, and burn-down charts. Common challenges to Scrum adoption are also reviewed.
Modul ini membahas cara membaca dan menggambar gambar teknik dengan benar, mencakup proyeksi gambar, gambar potongan, dan garis arsiran. Tujuannya agar siswa memahami cara membaca dan menggambar konstruksi teknik dengan tepat.
This document contains a list of Spanish words beginning with L repeated in a seemingly random order. Some of the words included are: letra, locomotora, lego, lámpara, lupa, llauna, lucas, and linterna. The list is not in alphabetical order and some words like lupa and lila appear multiple times throughout.
The document provides instructions for students to practice writing the letter N in Catalan. It lists words starting with N and asks students to write the words on the whiteboard. It then mentions making a shape with N letters and starting to write words using the letter N.
The document is a letter from a math teacher encouraging a student to take AP Computer Science based on their success in math. It details that AP Computer Science covers topics equivalent to a semester of college computer science, uses Java programming and Linux, and may provide college credit depending on exam scores. The teacher believes the student's math background will help them enjoy learning new computer science concepts like algorithms, data structures, and programming. Students are asked to fill out a form to select AP Computer Science for their course schedule.
One Global Logistics provides specialized import, customs, warehousing, and transportation services for glass and facade materials used in the building and construction industry. They have extensive experience importing over 1 million square meters of glass, windows, and doors in the last 5 years for projects throughout Australia. Their services include stillage design, customs clearance, freight forwarding, material handling, transportation and delivery, risk management, and coordinating import logistics from origin to site. They have successfully managed glass import projects for buildings like Deakin University, Medibank Building in Melbourne, and Westpac Building in Melbourne.
Brand Manual / Branding & Service Design 2016Brand Manual
A short introduction how to give your business a competitive edge by looking at it from the customers' point of view. Redesigning products and services to make them work better.
Why, what, an How of Agile Retrospectives - Lean Kanban Benelux 2015 - Ben Li...Ben Linders
Retrospectives help teams to deploy agile practices in an effective way and to continuously learn and improve themselves.The retrospective facilitator (often the scrum master) should have a toolbox of retrospective exercises, and be able to pick the most effective one.
The document discusses marketing strategies during the introduction stage of a new product. It outlines six key strategies: 1) Attracting customers through advertising, PR, and publicity; 2) Inducing customers to try the product through samples and pricing incentives; 3) Engaging in customer education; 4) Strengthening distribution channel relationships; 5) Building availability through trade promotion; 6) Setting pricing objectives to balance investment and market realities. It also categorizes new products based on their newness and discusses advantages of pioneering vs following strategies.
Dokumen tersebut membahas tentang proyeksi gambar teknik dan konstruksi geometri. Proyeksi gambar dibedakan menjadi proyeksi piktorial yang mendekati bentuk nyata dan proyeksi ortogonal yang menggunakan pandangan tetap. Proyeksi piktorial mencakup aksonometri, isometri, dimetri dan trimetri. Sedangkan proyeksi ortogonal terdiri atas kuadran I dan kuadran III. Dokumen juga menjelaskan konsep titik, gar
The Snail Entrepreneur: The 7-year-old kid every startup should learn fromClaudio Perrone
Matteo faced a seemly impossible problem, but didn't give up. He used daddy's #PopcornFlow and pivoted. 17 options and 5 experiments later, he converged to success.
PopcornFlow is impacting businesses (large and small) but also families and kids.
If you like this story, please contribute to Matteo's cause.
Kayla Wulff is seeking a position in sports business with experience in ticket sales, community relations, and player development. She has a Bachelor's degree in Sport Management and Professional Sales certificates. Her internships include working with the NFLPA in player affairs and development, the Jacksonville Jaguars in ticket sales, and the Johnson City Cardinals in community relations. She is proficient in ticketing and CRM software and has leadership experience planning conferences and managing donor relationships.
Social Media and Diversity: The ROI for Brands Andre Blackman
This is a panel presentation that I was apart of for 2015's SXSW Interactive conference. We lay out reasons for brands to get involved with diversifying the audiences they build relationships with and market toward. There is a sustainable ROI involved!
Agile development is both a philosophy and methodology for building products in an iterative and incremental way. It involves short development cycles called sprints where self-organizing cross-functional teams focus on continuously delivering working software. Daily stand-up meetings help ensure transparency and coordination across the team. While agile aims to be flexible and lightweight, some key practices like planning, pair programming, and tracking progress help teams stay aligned and deliver value continuously.
Addie Brooks has over 10 years of experience as a clinical research associate (CRA) leading clinical trials in various therapeutic areas such as oncology, respiratory diseases, infectious diseases, and more. She currently works as a lead CRA at INC Research, where her responsibilities include monitoring clinical trials, ensuring regulatory compliance, and providing guidance to junior CRAs. Previously, she held CRA roles at various CROs such as PPD and RPS, where she gained experience in project management, site monitoring, and training other staff.
This document provides a summary of Adewonuola Ajibade's professional experience as a Clinical Research Associate with over 5 years of experience in clinical trials. It outlines their therapeutic area experience, skills, work history including roles as a CRA I and CRA II, education, and technology experience.
Nan Wang worked as a Clinical Research Associate (CRA) at Quintiles Enterprise Management in Shanghai, China from July 2011 to April 2014. Her responsibilities included site selection, study start-up activities, monitoring clinical trials, creating monitoring reports, communicating with study teams, training site staff, and ensuring compliance. She monitored studies according to regulations and led mentoring of other monitors. Wang received several awards for her work in database lock and as a star CRA.
The document provides information on various stages of clinical trial processes:
1. It outlines the key stages in site selection, study start-up, study conduct, study closeout, and the roles and responsibilities of major players like investigators, clinical research associates, and monitors.
2. It then describes the processes involved in site selection, study closeout, and investigator and monitor responsibilities in more detail.
3. Finally, it discusses sample size determination and the factors and formula used to calculate the minimum required sample size for accuracy in clinical trials.
Clinical trials are scientific studies that test new medical treatments or interventions on human volunteers. They are conducted by pharmaceutical companies or contract research organizations to evaluate the effects, risks, benefits, and efficacy of new drugs, biologics, or devices prior to their market release. Major players in a clinical research team include investigators, clinical research associates, coordinators, data managers, statisticians, patients, institutional review boards, and regulatory bodies. Principal investigators are responsible for leading the clinical trial team at each study site and ensuring proper conduct of the trial according to protocol and regulations.
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptxE Poovarasan
This document outlines the roles and responsibilities of key personnel in clinical trials, including the investigator, study coordinator, and other members of the research team. It describes that the investigator is responsible for conducting the trial according to the protocol and protecting participants. The study coordinator works under the investigator and is responsible for coordinating study visits, obtaining consent, and ensuring compliance. Other duties of the research team include reporting adverse events, maintaining proper records, and following Good Clinical Practice standards.
Sakshi Rawat is seeking a position that utilizes her clinical research experience and knowledge. She has over 6 years of experience in clinical research roles at Tata Consultancy Services, Ambrosia Life Sciences, and Indraprastha Apollo Hospitals. Her experience includes clinical trial coordination, monitoring, data management, and ensuring compliance. She has a post-graduate certificate in clinical research and skills in EDC systems, MS Office, and regulatory guidelines like ICH-GCP.
Christopher Brawley has over 7 years of experience in clinical trial management and coordination. He is currently a Clinical Trial Manager at Natera Inc. where he is responsible for implementing large clinical trials according to study protocols. Previously he held clinical trial management roles at Gilead Sciences and Stanford University with responsibilities including developing study documents, training staff, monitoring trials, and generating reports. He has a BS in Molecular Biology from the University of Illinois.
Jamie D. Gross has over 20 years of experience in clinical research as a clinical research coordinator, associate, project manager, and lead. She currently serves as a Clinical Lead for QuintilesIMS, where she manages operational aspects of projects, ensures study quality and patient recruitment, and leads and mentors the clinical operations team. She has extensive experience implementing study protocols, training sites, and overseeing clinical monitoring.
Felicia Phillips has over 15 years of experience in clinical research. She holds a Bachelor's degree in Business Administration and an Associate's degree in Microcomputing. Her experience includes roles as a Clinical Research Associate, Clinical Trial Associate, and Clinical Study Coordinator for organizations such as PRA HealthSciences, Research Pharmaceutical Services, GlaxoSmithKline, Children's Hospital of Philadelphia, and Clinsys Clinical Research. Her responsibilities have included investigator recruitment, regulatory document management, clinical trial budgeting and supplies management, and ensuring compliance with Good Clinical Practice guidelines. She is proficient in several clinical research database and document management systems.
This document is a curriculum vitae for Kelly Bartholomew, a clinical team manager with over 10 years of experience in clinical research. It lists her work history as a clinical team manager, clinical research associate, and in-house clinical research associate at PRA. Her roles and responsibilities have included managing clinical teams and studies, monitoring sites, ensuring regulatory compliance, addressing issues, and training other staff. She has experience across multiple therapeutic areas and phases of research. The CV highlights her accomplishments such as awards, positive performance reviews, and mentoring other employees.
Roger Hutson is a clinical research professional with over 20 years of experience in project leadership and management. He has extensive experience conducting all phases of clinical trials in various therapeutic areas, including oncology, neurology, and infectious diseases. His background includes roles as a senior clinical research associate, clinical team leader, budget compliance officer, and clinical research consultant.
Alex Rodas has over 20 years of experience as a clinical research coordinator and executive assistant at UCSF. He has extensive experience coordinating clinical trials in various therapeutic areas and managing all aspects of clinical research studies including participant recruitment and screening, data collection, regulatory documentation, and quality assurance. Rodas holds certifications as a Clinical Research Coordinator and Given Capsule Technician. He has co-authored several peer-reviewed journal articles on clinical research studies.
This document provides a summary of Yolanda B. Latta's experience and qualifications. She has over 15 years of experience in clinical operations roles in the pharmaceutical industry, across multiple therapeutic areas. She is proficient in various clinical trial databases and systems. Her experience includes roles managing clinical trial sites and protocols, ensuring regulatory compliance, and providing operational support for clinical studies.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
Career Paths of Clinical Research Coordinators.pptxrainj2
What is Clinical Research Coordinator
A clinical research coordinator is a research professional who helps in formulating, enforcing, and organizing research processes to conduct clinical trials at a research center, hospital, or healthcare center. They perform various administrative duties, collects and documents patient data, and ensure compliance with all relevant government law and regulations.
The Clinical research coordinator oversees and performs medical research and clinical trials to test drugs or other interventions. They work with a team of clinical research associates to determine and follow the study procedures and protocols. Clinical research coordinators may work for hospital research departments, research institutions, pharmaceutical companies, or private businesses.
Clinical research coordinators have some specialized and technical skills. These include communications, professional demeanor, a strong background in health education, interpersonal skills, empathy, organization, and research.
Clinical research coordinator responsibilities
A clinical research coordinator is responsible to perform various duties
• Collecting data, coding, and analyzing from research
• Managing budgets for research
• Overseeing the trouble-free handling of clinical trials
• Communicating with participants about the study objective
• Directing the collection, labeling, storage, and transport of all specimen
• Monitoring to ensure the study complies with protocols
• Maintain research records for study activity
• Make sure that all equipment and supplies needed for the study are in stock
How to Become a Clinical Research Coordinator
Steps: Explore clinical research coordinator education: - If you are interested in becoming a clinical research coordinator, one of the first things to consider is how much education you need. The clinical research coordinator must have a bachelor’s degree.
Develop clinical research coordinator skills: - It will be a good idea to develop clinical research coordinator skills before applying for a job.
Complete applicable training or internship: - Clinical research coordinators spend normally 1-3 months on post-employment on-the-job training.
Get clinical research coordinator certification: - Certification can show employers you have a piece of knowledge about the clinical research coordinator job post
Research clinical research coordinator duties: - When you decide to become a clinical research coordinator, it’s important to know what duties and responsibilities are required for this position.
Apply for a clinical research coordinator job: - After completion of training you had to apply for a clinical research coordinator job post
To become a clinical research coordinator, aspirants need a combination of specialized education, training, and skills. Many research centers prefer their clinical research coordinators to hold a clinical research coordinator certificate or diploma.
Elizabeth Hirner has extensive experience in counseling, research, and regulatory compliance. She has a BS in Developmental Psychology, a Psych Tech Certification, and is pursuing a Master of Social Work. Her current internship involves assessments, individual and group therapy, documentation, and referrals as a counseling intern. Previous internships and positions involved assisting cancer patients, students with special needs, and coordinating twin research. She has strong skills in counseling, research, compliance, communication, and using various software programs.
Masood M Khan has over 13 years of experience as a Clinical Research Associate (CRA) monitoring clinical trials across multiple therapeutic areas. He has worked at several contract research organizations, most recently as a Senior CRA at United BioSource Corporation. His experience includes conducting monitoring visits, writing monitoring reports, training other staff, and ensuring protocol and regulatory compliance at investigative sites. He holds an MD from Deccan College of Medical Sciences in India and is proficient in English, Urdu, Hindi, Arabic, Farsi, and Pashto.
Miranda Haith has over 14 years of experience as a clinical research project manager, primarily in oncology trials. She has a proven track record of leading clinical research teams, developing study plans and protocols, managing study timelines and budgets, and ensuring regulatory compliance. Her expertise includes all phases of oncology clinical trials using RECIST v1.1 for tumor response and electronic data capture systems. She is proficient in Microsoft Office, clinical trial management systems, and has worked with pharmaceutical companies and contract research organizations.
Audit, inspection and monitoring in clinical trial by Ashish singh pariharDr. Ashish singh parihar
1. Audits, inspections, and monitoring are important quality assurance activities to ensure clinical trials are conducted properly and that human subjects and data are protected.
2. Audits examine trial activities and documents, inspections review documents and facilities for compliance, and monitoring oversees trial progress on an ongoing basis.
3. The main types of monitoring visits are pre-study visits to qualify sites, initiation visits to train staff, periodic visits to check compliance, and termination visits to close out the study.
Audit, inspection and monitoring in clinical trial by Ashish singh parihar
062016CV_Johnson_Debra [147732]
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Debra Johnson, BS, CCRC, LPN
North Port, Florida
Senior Clinical Research Associate
(941) 822-9661
Office: (941) 423-4017
EDUCATION University of Phoenix, Phoenix, AZ
Bachelors of Science, Health Administration, 2013
University of Phoenix, Phoenix, AZ
Associate of Arts, 2012
Manatee Community College, Venice, FL
Licensed Practical Nurse, 1996
WORK
EXPERIENCE
Jul 2016- Present Harvard Clinical Research Institute, Boston, MA
Senior Field Monitor
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
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Feb 2016 -Jul 2016
Dec2015-Feb 2016
PRA International assigned to Merck, Bluebell, PA
Senior Clinical Research Associate
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
Intercoastal Medical Group, Sarasota, Fl
Certified Clinical Research Coordinator (since 1998)
• Assist hospitals to implement IRB/Ethic Committee internal systems
to support clinical research
• Perform all aspects of study coordination including phlebotomy and
lab processing from study start-up through close-out for both
inpatient and outpatient studies while adhering to ICG/GCP
Guidelines
• Data Entry in electronic data capture systems
• Manage IWRS for individual studies
• Maintain and update Regulatory Documents
• Conducted in-services for hospital staff prior to implementing clinical
studies
• Reason left position: Return to corporate position
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Jun 2014 to Dec
2015
Inventiv Clinical Health, Inc, Charlotte, North Carolina
Dedicated to Novo Nordisk (Contract/FSP)
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Sponsor project
management team
• Performed lead CRA responsibilities on assigned projects
• Review of subject Diaries and Questionnaires (electronic and paper)
Reason for leaving: Family emergency. On FMLA due to death in
immediate family (son).
MAR 2014 to JUN
2014
Research Pharmaceutical Services, Inc. (Contract)
Senior Site Manager
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
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preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
• Perform co-monitoring visits and performance assessment visits,
when properly trained and delegated by Clinical Research Manager
• Ensure the integrity of clinical data and adherence to applicable
regulatory, protocol, and company guidelines.
• Establish and maintain good rapport with study sites.
• Write study visit reports and follow up letters within the timeline
established by applicable SOPs and guidelines
• Coordinate timely shipment of clinical supplies and study drug to sites
• Ensure proper storage, dispensation and accountability of clinical
supplies and study drug.
• Maintain adequate site tracking records.
• Follow up of drug safety issues and safety reports in timely manner, if
applicable.
• Communicate site study issues, concerns, and progress to Clinical
Research Manager, Project Manager and Clinical Team Lead
accordingly.
• Assist with data query form (incl. query process).
• Perform telephone- monitoring activities in order to obtain study status
information.
• Development and implementation of corrective actions when
appropriate.
• Prepare /review all patients tracking records.
• Input and maintain study information concerning subject status of
financial reimbursement to sites.
• Conduct and assist with administrative activities as a member of the
project team.
• Mentor for Site Manager and/or Site Manager II, when assigned
• Conduct on the job training and formal training to other Site Managers.
• Collaborate with Clinical Research Manager/ study teams to resolve
site issues
• Review study visit reports, follow-up letters and site communication
generated by other site managers for timeliness, quality, consistency,
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and appropriate documentation and resolution of issues, with support
from Clinical Team Lead or Clinical Research Manager as needed.
• Participate in routine study progress meetings, face to face or via
teleconference.
Reason for leaving: RPS was acquired by PRA and client initiated
re-organization of in-house support team. Rehired 2/2016
DEC 2013 to MAR
2014
INC Research, Raleigh, NC (Contract)
Senior/Lead Clinical Research Associate
• Tracking of regulatory documents in Trial Master File
• Reconciliation of Serious Adverse/Clinical Endpoint event
queries/supporting documentation
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and project management
team
• Contribute/lead team meetings
Reason for leaving: Project hired to lead was cancelled by client within 3
weeks of hire. Other position offered was not a lead position.
JUL 2013 to DEC
2013
Inventiv Clinical Health, Inc, Charlotte, North Carolina
Dedicated to Allergan (Contract/FSP)
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out, including site set-up for eye exams, and performing all start-up
activities including obtaining the CDA.
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations. Collected updated
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documents and forwarded them to appropriate in-house resources.
• Set up/requested site access to IWRS, learning and EDC systems
• Served as liaison between the study sites and Inventiv/Allergan
project management team
• Performed quality checks on mandated study systems at the site level
Reason for leaving: Allergan was sold, contract was cancelled
Role-JAN 2013 to
JUL 2013
(Employed at
Covance)
Jun2007-
JUL2013)
Covance Clinical Development Services, Princeton, NJ
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Covance project
management team
• Spear-headed recruitment plans at individual sites identified as low
enrollers
• Initiated communications with sites during cohort teleconferences
• Initiated site plans for resolution of queries for data cleaning cycles
Reason for leaving: Desired smooth transition from Project Manager back
to CRA
JUL 2012 to JAN
2013
Covance Clinical Development Services, Princeton, NJ
Project Manager, Oncology, Early Clinical Development
• Leaded the core project team as directed by Project Director(s) to
facilitate their ability to lead the project team
• Spear-headed cross unit coordination both internally and externally,
inclusive of sub-contractors for projects utilizing one or more
Covance services or sites
• Tracking of project resource needs and contribute to contingency
planning for key resources
• Assist in monthly financial reconciliation activities/meetings (hours
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SEP 2009 to JUL
2012
burned, etc.)
• Management of vendors including conducting monthly/adhoc
meetings and managing logistical issues
• Initiation of a successful design, implementation, tracking, and
revision of project plans for assigned projects
• Contribute to improvements to enhance the efficiency and the
quality of the work performed on assigned projects
• Ensure that all staff allocated to assigned projects adhere to
professional standards and SOPs established for clinical research
• Provide performance feedback of team members to respective
supervisors
• Acted as a lead recruitment specialist developing process and
procedures for individual sites in an effort to optimize enrollment
Reason for leaving: Desire to return to a position that interacted more
directly with sites in the clinical environment.
Covance Clinical Development Services, Princeton, NJ
Associate Project Manager
• Assist in the leadership of the core project team as directed by
PM/SPM/PD to facilitate their ability to lead the project team
• Assist in the cross unit coordination both internally and externally,
inclusive of sub-contractors for projects utilizing one or more
Covance services or sites
• Assist in the management and tracking of project resource needs
and contribute to contingency planning for key resources
• Assist in monthly financial reconciliation activities
• Management of vendors including conducting monthly meetings and
managing logistical issues
• Assist in the successful design, implementation, tracking, and
revision of project plans for assigned projects
• Contribute to improvements to enhance the efficiency and the
quality of the work performed on assigned projects
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8. Revised 07/2016
JUN 2007 to SEP
2009
APR 2007 to JUN
2007
• Ensure that all staff allocated to assigned projects adhere to
professional standards and SOPs established for clinical research
• Provide performance feedback of team members to respective
supervisors
• Perform other duties as assigned by management
• Acted as a lead recruitment specialist developing process and
procedures for individual sites in an effort to optimize enrollment
• Site selection for new studies (initiated questionnaire, complied and
tracked answers to feasibility questions)
Covance Clinical Development Services, Princeton, NJ
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial
was conducted in compliance with the currently approved protocol,
with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Covance project
management team
• Performed lead CRA responsibilities on assigned projects such as
initiate study-wide query reports, tracking of query resolution, and
trip report review/approval
• Contribute to content of newsletter
• Lead weekly/monthly CRA meetings
• Quality control visits for CRAs
• Review/tracking of CRA expenses
MDS Pharma Services, Irvine, CA
Clinical Team Leader
• Conducted all aspects of clinical trial monitoring from screening to
close-out
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JUL 2002 to APR
2007
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; that reported trial data are
accurate, complete, and verifiable from source documents, and that
the trial is conducted in compliance with the current approved
protocol, with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and MDS Pharma project
management team
• Performed lead CRA responsibilities on assigned projects
• Participated in developing departmental procedures and initiatives to
improve process/efficiencies
• Acted as a mentor to less experienced CRAs and assisted in their
development and training
• Participated in recruitment of new staff
• Management of direct reports including expense report review,
project allocation, trip report review, and ongoing training for new
and established clinical research associates
MDS Pharma Services, Irvine, CA
Senior Clinical Research Associate
• Conducted all aspects of clinical trial monitoring from screening to
close-out
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; that reported trial data are
accurate, complete, and verifiable from source documents, and that
the trial is conducted in compliance with the current approved
protocol, with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and MDS Pharma project
management team
• Performed lead CRA responsibilities on assigned projects
• Participated in developing departmental procedures and initiatives to
improve process/efficiencies
• Acted as a mentor to less experienced CRAs and assisted in their
development and training
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JUL 1996 to JUL
2002
THERAPEUTIC
AREA
EXPERIENCE
• Participated in recruitment of new staff
Reason for leaving: MDS was acquired by INC and new offer for
better position as lead CRA
Heart Center Research, Port Charlotte, FL
Certified Clinical Research Coordinator / Manager
• Managed clinical research staff at multiple locations
• Assisted hospitals to implement IRB/Ethic Committee internal
systems to support clinical research
• Performed all aspects of study coordination including phlebotomy
and lab processing from study start-up through close-out for both
inpatient and outpatient studies
• Performed standard nursing duties in cardiac catheterization
laboratory including management of arterial lines and preoperative
and post-operative care
• Conducted in-services for hospital staff prior to implementing clinical
studies
Reason for leaving: Offer for CRA position
Phase I – Neurology-Parkinson’s Disease
Phase II – Oncology-Breast CA, Pancreatic CA, Metastatic Liver CA,
Kidney CA, Childhood Leukemia, Melanoma, Multiple Myeloma,
Lymphoma (Hodgkin’s and non-Hodgkin’s) Infectious Disease-
Complicated Urinary Tract Infection, Complicated Intra-Abdominal
Infections, Cardiology-Atrial Fibrillation, Acute Myocardial Infarction,
Hyperlipidemia, Acute Coronary Syndrome, Hypertension, Claudication,
Ventricular Tachycardia Hematology- Chemotherapy Induced Anemia,
Sickle Cell Anemia, Graft Versus Host Disease, Endocrinology- Types-1
and 2 Diabetes Mellitus, Obesity Neurology-Migraine
Phase III –Cardiology-Atrial Fibrillation, Acute Myocardial Infarction,
Hyperlipidemia, Acute Coronary Syndrome, Hypertension, Claudication,
Hematology-Anemia Endocrinology- Type-2 Diabetes Mellitus
Dermatology-Hypotrichosis, Urology-Overactive Bladder,
Ophthalmology: Dry Eye Syndrome Oncology- Breast Cancer (PR/HR
neg, HER2), Melanoma, Solid Tumors
Phase IV –Cardiology-Hypertension, Hyperlipidemia, Diabetes
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CURRENT
PROFESSIONAL
AFFILIATIONS
Member Association of Clinical Research Professionals since 1996, So
CRA
ADDITIONAL
RELEVANT
TRAINING
Leadership Training-Covance
Quality of Life (QO) Questionnaires
Mini-Mental State Examination (MMSE)
Rankin Stroke Scale
New York Heart Association Heart Failure Classification (NYHA)
RAVE
Inform 4.0, 4.5, 5.0
CURRENT
LICENSURE &
CERTIFICATIONS
Florida Department of Nursing PN 1233441 (Expiration Jul 2017)
Certified Clinical Research Coordinator (Expiration Nov 2017)
COMPUTER
SKILLS
Word, Excel, PowerPoint, Oracle, MediData, RAVE, Inform, Informatics,
Outlook
LANGUAGES English
PROFESSIONAL
HONORS &
AWARDS
Ace Award of Excellence-Covance 2010
Signature________________________________ Date__________________
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