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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This document provides an evaluation of a health program. It discusses the purpose and types of program evaluation, including formative vs summative and internal vs external evaluations. Key aspects of programs that can be evaluated are outlined, such as accessibility, equity, quality, effectiveness, efficiency, and sustainability. A variety of tools for evaluation are mentioned, including surveys, case studies, and root cause analysis. The document also provides an example of evaluating India's National Program for the Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke.
Yuriy Kravtsiv has over 15 years of experience in clinical research and medical practice. He has worked as a senior clinical research associate, medical psychologist, and clinical immunologist. His experience includes conducting clinical studies in various therapeutic areas such as infectious diseases, gastroenterology, cardiology, psychiatry, oncology, and pulmonology. He is fluent in Ukrainian, Russian, and English.
Strategies for Auditors to Prepare Clinical Research Personnel For a Regulato...IMARC Research
Strategies for Auditors to Prepare Clinical Research Personnel For a Regulatory Inspection: a Presentation by Paul Cobb, MPH, CCRA
Clinical Auditor, IMARC Research
Marta Walewska is a senior manager of clinical operations with 13 years of experience in clinical research. She has 6 years of experience as a clinical research associate and is fluent in Polish, English, and has a passive knowledge of Russian and German. She has a medical doctor degree and specializes as a pediatrician. Her experience includes managing clinical operations staff across several countries, building relationships with investigators, developing standard operating procedures, and ensuring compliance.
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.
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.
Stacy H. Flannery has over 15 years of experience in clinical research and regulatory compliance. She has expertise coordinating Phase II and III clinical trials in areas such as otology, neurology, oncology and diabetes. Her skills include managing clinical trial sites, monitoring data, addressing queries, and ensuring regulatory compliance. She is proficient in clinical data systems and holds certifications in Good Clinical Practice. Flannery also has a background in public policy, healthcare administration, and event planning.
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.
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.
Engage and Retain Patients in Long-term Observational StudiesJohn Reites
Traditionally, real-world and late phase studies require sites to enroll, engage and retain patients and collect and record patient reported outcomes (PRO), which can be burdensome to both sites and patients. Overtime, sites and patients may lose motivation to participate, contributing to high patient dropout rates, increased study costs and site dissatisfaction. This session will focus on innovative approaches for effectively engaging and retaining patients in long-term studies, such as: identifying design and operational considerations with conducting long-term observational research, understanding site and patient retention challenges, and examining engagement strategies and opportunities for improving retention and compliance.
This chapter discusses developing metrics to support projects, interventions, and programs. It covers the Institute for Healthcare Improvement's framework, including identifying areas for improvement, selecting measures, obtaining a baseline, and remeasuring. The chapter also discusses organizational readiness, levels of evidence, cost analyses, selecting appropriate variables, and developing a data management plan including defining needs, identifying sources and measures, designing studies, retrieving and analyzing data. The goal is to select meaningful metrics to quantify cost and quality to improve outcomes as the healthcare system reforms.
Laura Gontz has over 20 years of experience in nursing, quality management, risk management, and patient safety. She has expertise in patient centered medical homes, performance improvement, meaningful use, and core measure initiatives. Her background includes roles in emergency care, pain management, cardiology, infection control, and quality analysis.
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.
The document discusses the importance of planning in dental health programs. It outlines the key steps in planning which include conducting a needs assessment, determining priorities, developing goals and objectives, identifying resources and constraints, implementation, supervision, evaluation and revision. Surveys are an important part of the planning process as they are used to collect basic oral health information on disease patterns, treatment needs and existing programs. This information is then used to inform the planning, implementation and monitoring of dental health services.
Una caja negra es un elemento estudiado por sus entradas y salidas sin considerar su funcionamiento interno. Se define por su interfaz de entrada y salida, pero no por sus detalles internos. Se dan ejemplos de cajas negras como una michelada, agua de limón, huevos fritos y parques infantiles y acuáticos.
El documento proporciona información sobre el escudo de armas de la ciudad de Valladolid, que data de 1454 y pudo haber sido otorgado por el rey Enrique IV de Castilla. Describe los elementos que componen el escudo, incluyendo la bordura de gules con ocho castillos de oro y la cruz laureada de San Fernando. También presenta una breve historia de la ciudad y algunos de sus principales monumentos y atracciones turísticas.
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.
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.
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.
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.
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.
This document provides an evaluation of a health program. It discusses the purpose and types of program evaluation, including formative vs summative and internal vs external evaluations. Key aspects of programs that can be evaluated are outlined, such as accessibility, equity, quality, effectiveness, efficiency, and sustainability. A variety of tools for evaluation are mentioned, including surveys, case studies, and root cause analysis. The document also provides an example of evaluating India's National Program for the Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke.
Yuriy Kravtsiv has over 15 years of experience in clinical research and medical practice. He has worked as a senior clinical research associate, medical psychologist, and clinical immunologist. His experience includes conducting clinical studies in various therapeutic areas such as infectious diseases, gastroenterology, cardiology, psychiatry, oncology, and pulmonology. He is fluent in Ukrainian, Russian, and English.
Strategies for Auditors to Prepare Clinical Research Personnel For a Regulato...IMARC Research
Strategies for Auditors to Prepare Clinical Research Personnel For a Regulatory Inspection: a Presentation by Paul Cobb, MPH, CCRA
Clinical Auditor, IMARC Research
Marta Walewska is a senior manager of clinical operations with 13 years of experience in clinical research. She has 6 years of experience as a clinical research associate and is fluent in Polish, English, and has a passive knowledge of Russian and German. She has a medical doctor degree and specializes as a pediatrician. Her experience includes managing clinical operations staff across several countries, building relationships with investigators, developing standard operating procedures, and ensuring compliance.
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.
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.
Stacy H. Flannery has over 15 years of experience in clinical research and regulatory compliance. She has expertise coordinating Phase II and III clinical trials in areas such as otology, neurology, oncology and diabetes. Her skills include managing clinical trial sites, monitoring data, addressing queries, and ensuring regulatory compliance. She is proficient in clinical data systems and holds certifications in Good Clinical Practice. Flannery also has a background in public policy, healthcare administration, and event planning.
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.
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.
Engage and Retain Patients in Long-term Observational StudiesJohn Reites
Traditionally, real-world and late phase studies require sites to enroll, engage and retain patients and collect and record patient reported outcomes (PRO), which can be burdensome to both sites and patients. Overtime, sites and patients may lose motivation to participate, contributing to high patient dropout rates, increased study costs and site dissatisfaction. This session will focus on innovative approaches for effectively engaging and retaining patients in long-term studies, such as: identifying design and operational considerations with conducting long-term observational research, understanding site and patient retention challenges, and examining engagement strategies and opportunities for improving retention and compliance.
This chapter discusses developing metrics to support projects, interventions, and programs. It covers the Institute for Healthcare Improvement's framework, including identifying areas for improvement, selecting measures, obtaining a baseline, and remeasuring. The chapter also discusses organizational readiness, levels of evidence, cost analyses, selecting appropriate variables, and developing a data management plan including defining needs, identifying sources and measures, designing studies, retrieving and analyzing data. The goal is to select meaningful metrics to quantify cost and quality to improve outcomes as the healthcare system reforms.
Laura Gontz has over 20 years of experience in nursing, quality management, risk management, and patient safety. She has expertise in patient centered medical homes, performance improvement, meaningful use, and core measure initiatives. Her background includes roles in emergency care, pain management, cardiology, infection control, and quality analysis.
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.
The document discusses the importance of planning in dental health programs. It outlines the key steps in planning which include conducting a needs assessment, determining priorities, developing goals and objectives, identifying resources and constraints, implementation, supervision, evaluation and revision. Surveys are an important part of the planning process as they are used to collect basic oral health information on disease patterns, treatment needs and existing programs. This information is then used to inform the planning, implementation and monitoring of dental health services.
Una caja negra es un elemento estudiado por sus entradas y salidas sin considerar su funcionamiento interno. Se define por su interfaz de entrada y salida, pero no por sus detalles internos. Se dan ejemplos de cajas negras como una michelada, agua de limón, huevos fritos y parques infantiles y acuáticos.
El documento proporciona información sobre el escudo de armas de la ciudad de Valladolid, que data de 1454 y pudo haber sido otorgado por el rey Enrique IV de Castilla. Describe los elementos que componen el escudo, incluyendo la bordura de gules con ocho castillos de oro y la cruz laureada de San Fernando. También presenta una breve historia de la ciudad y algunos de sus principales monumentos y atracciones turísticas.
El documento describe los sistemas operativos, definidos como el software básico de una computadora que administra los recursos hardware, coordina los dispositivos y organiza archivos. Explica que los sistemas operativos más comunes son Windows, Linux, MacOS y DOS, y clasifica los sistemas operativos en monotareas o multitareas, monousuarios o multiusuarios, y centralizados o distribuidos.
El tableau vivant es una expresión francesa que se refiere a la representación de obras pictóricas mediante grupos de personas que posan como los personajes de la pintura. Sus orígenes se remontan al siglo XIX como una forma de entretenimiento donde las personas usaban trajes y posaban de forma estática para simular cuadros famosos. El documento presenta algunos ejemplos de cuadros famosos que han sido recreados a través del tableau vivant.
This document is an email advertising case solutions and analyses for the Amtelecom Group Inc case study from Ivey Publishing. It provides contact information for ordering case solutions from various publishers at casesolutionsavailable@gmail.com. The email lists publishers whose case solutions they provide, including Harvard Business School, Ivey Publishing, Darden School of Business, and others.
Rebecca Pierce is an experienced educational professional seeking an administrative position. She holds doctorate and multiple master's degrees in education-related fields from Capella University and Grand Canyon University, maintaining a GPA of 4.0 or higher in all programs. Pierce has over 25 years of experience in education, most recently as the Reading Coach at Loughman Oaks Elementary School where she implemented collaborative structures and mentored teachers. Prior to that, she held various teaching and resource positions at Eastside Elementary School and schools in Nashville.
Hedge funds pool together investor capital to engage in aggressive trading strategies with the goal of higher returns than mutual funds. They are typically only available to high net worth individuals who can invest at least $1 million. Hedge funds have a general partner who manages the fund and limited partners who are the investors. In addition to management fees, hedge funds often charge incentive fees based on profits earned. Investors also have limited liquidity, as some funds only allow withdrawals on a monthly or quarterly basis.
The email is a request from a student named Maria to her English teacher asking if she can submit her homework assignment late. Maria explains that she has been sick with a cold and unable to finish the homework on time. She asks if she can turn it in the next day and promises it will be completed.
Este documento describe los beneficios del expediente judicial electrónico sobre el expediente en papel, incluyendo una mayor eficiencia, acceso público, seguridad y menor riesgo de pérdida de documentos. También presenta ejemplos de países como Uruguay y Chile que han adoptado con éxito el expediente judicial electrónico y discute los esfuerzos iniciales del Poder Judicial del Perú para implementar un sistema similar.
Juana Belén Amaya aplicó el aprendizaje flexible en su salón de segundo grado, tomando en cuenta el ritmo individual de aprendizaje de los estudiantes y usando herramientas tecnológicas. Ella propuso actividades lúdicas, recreativas y académicas que estimularon la imaginación y creatividad de los estudiantes, creando un ambiente escolar que facilitó el aprendizaje. Tanto estudiantes como docentes disfrutaron del ambiente respetuoso y aportaron iniciativa y creatividad para lograr claramente los
Un sistema computacional consiste en hardware físico, software de aplicaciones e instrucciones lógicas que interactúan para procesar datos y mostrar resultados. El hardware incluye dispositivos de entrada, salida y almacenamiento, mientras que el software se compone de aplicaciones de usuario y sistemas operativos. Juntos, estas partes permiten que los usuarios utilicen el sistema para completar tareas específicas.
El documento describe el origen y la influencia del muralismo mexicano en Chile. Los muralistas mexicanos como Siqueiros, Orozco y Rivera produjeron obras monumentales para el pueblo que retrataban la realidad y luchas sociales de México. Este movimiento surgió después de la revolución mexicana de 1910 y los muralistas se convirtieron en cronistas de la historia y nacionalismo de México. Más tarde, el muralismo mexicano influyó en el desarrollo del muralismo chileno a través de artistas
Corrosion under insulation is a common problem that can occur when pipes and vessels are insulated. The document discusses facts about corrosion under insulation and ways to prevent it from occurring. It was written by Kumar Kolur Vadivelu from Sadara Chemical Company and thanks the reader.
El documento presenta una introducción a la toma de decisiones, describiendo que es el proceso mediante el cual se elige entre alternativas para resolver situaciones. Luego detalla diversos temas y subtemas relacionados a la toma de decisiones, incluyendo tipos de problemas, barreras, y etapas del proceso de toma de decisiones como diagnóstico, planificación e implementación. Finalmente, ofrece una definición de decisiones programadas y no programadas, y la importancia de elegir una técnica adecuada para la toma de decisiones.
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 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 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.
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.
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.
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.
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.
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.
- Thanuja T has over 9 years of experience in clinical data management, primarily working in oncology.
- She has worked at Quintiles as an Assistant Manager for the past 6 years managing clinical data and a team of 7 reports.
- Prior to Quintiles, she worked at Accenture and Jubilant Biosys in data validation and research roles respectively.
Lila Killensworth has over 20 years of experience in the pharmaceutical industry, including expertise in clinical trial development, contracting, budgeting, and regulatory submissions. She has worked in managerial roles at several large pharmaceutical companies, where her responsibilities included negotiating contracts and budgets with investigative sites, developing regulatory submissions, and managing clinical operations. She has extensive experience in phases 1-4 clinical trials across multiple therapeutic areas.
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.
Sheila Y. Lister has over 25 years of experience in business administration and clinical research. She currently serves as Senior Coordinator of Clinical Studies at The University of Texas MD Anderson Cancer Center, where she oversees clinical trial operations and personnel. Previously, she held administrative roles at the City of Houston Health and Human Services and The University of Texas MD Anderson Cancer Center. She has a Bachelor's degree in Business Administration and an Associate's degree in Business.
- The document provides a summary of the professional experience of Thanuja T, including over 10 years of experience in clinical data management and project management roles, primarily at Quintiles. Some of the key responsibilities and experiences mentioned include serving as a Data Team Lead for 4 oncology projects at Quintiles, managing a team of 7 members, involvement in clinical data management from study start up to database lock, and experience working with data standards and platforms like INFORM, RAVE, and OC/RDC.
Irene Krohn is a senior clinical project coordinator with over 10 years of experience coordinating multi-center international clinical projects. Her responsibilities have included study file maintenance, project planning and reporting, budget and finance management, and coordinating third-party vendors. She has broad experience working on global projects and dealing with confidential information.
Andrejs Faibusevics has over 11 years of experience in clinical research, most recently as a Regulatory Start-Up Manager at Quintiles. He has significant experience managing global and regional clinical trials in various therapeutic areas including influenza, HIV, diabetes, and osteoporosis. His responsibilities have included regulatory start-up activities, clinical operations management, site monitoring, and ensuring compliance. He holds an MD from the Latvian Medical Academy.
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.
Project management in clinical research sanjay akhani 8 maySanjay Akhani
This document discusses project management in clinical research. It begins with a disclaimer from the presenter. It then provides an overview of key aspects of project management in clinical research, including project management tools and techniques used, components of a project management plan, managing contract research organizations and site management organizations, optimizing patient recruitment, and working with remote and multicultural teams. Challenges of working with remote and multicultural teams include differences in communication styles, work ethics, decision making, and views of time and change due to cultural differences between high and low context cultures.
Monica Putman has over 20 years of experience in investigations, project coordination, and administrative support roles. Her experience includes conducting investigations to detect fraud for a Medicaid special investigations unit, coordinating internal audits, and providing executive level administrative support. She has strong research, analytical, and communication skills and experience maintaining databases and case management systems.
1. 1KRISTI J. LATORRE, BSN, MBA
5984 Cherryview Lane kristilatorre@gmail.com
Bethel Park, PA 15102 (724)328-3366
Employment History
PPD, Remote based-Pittsburgh, PA- Nov. 2015- Present
Clinical Team Manager:
• Manage the execution of project deliverables within contractual timelines and client
expectations through all active phases (start-up, recruitment; maintenance; closeout-
database lock) of a trial
• Currently Responsible for re-structuring all processes involved in the early clinical phase
department.
• Manage clinical resources (CRAs/administrative team) according to projections of ongoing
clinical activities to ensure maximum resources are allocated to maintain forward
movement of clinical deliverables
• Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for
inclusion in a contract modification
• Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject
visits, query, etc.) to external/internal clients/vendors
• Manage contingency planning for data cleaning; clinical data listings review; and,
coordinate process for reviewing data listings by clinical team
• Prepare monitoring plan, as well as responsible for the implementation and training of
standardized clinical monitoring processes within the study team
• Oversee the development of source documents, CRF/eCRF guidelines and other project-
specific forms to be utilized during the study period
• Participate in site recruitment and budget negotiations
• Perform secondary clinical review of case report forms for the purposes of discovery of
query trends and CRA re-education
• Provide leadership, coordination, and management of the PPD-customer joint project team
through start-up, conduct, tracking, quality, and regulatory compliance management and
close-out activities
• Perform review of pass-thru travel costs to ensure the most cost-effective travel practices
are being utilized by monitoring staff
• Perform review of trip reports of team CRAs to ensure monitoring activities are
appropriately conducted and documented for the client according the contractual
obligations
• Review essential regulatory documents prior to transmittal to the client for release of initial
investigational product
• May present at Investigator Meetings
2. Covance Clinical Development Services, Princeton, NJ, USA – Apr. 2012 – Nov.15
Senior Clinical Research Associate – Mar. 2013 – Present
• Responsible for all aspects of study site monitoring including routine monitoring and
close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities:
o Ensure the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the
applicable regulatory requirements
o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or
other data collection tools by careful source document review
o Monitor data for missing or implausible data
o Ensure the resources of the Sponsor and Covance are spent wisely by
performing the required monitoring tasks in an efficient manner, according to
SOPs and established guidelines, including managing travel expenses in an
economical fashion according to Covance travel policy
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director as assigned
• Serve as lead monitor for a protocol or project, and may assist in establishing
monitoring plans and trip report review as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate needs, resources and timelines
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Conduct, report and follow-up on Quality Control Visits (CQC) when requested
3. • Recruitment of potential investigators, preparation of EC submissions, notifications to
regulatory authorities, translation of study-related documentation, organization of meetings
and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist the Covance legal
department with statements of agreements as assigned
• Complete process of Serious Adverse Event (SAE) reporting, process production of
reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems as
assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Co-ordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management
Clinical Research Associate – Apr. 2012 – Mar. 2013
• Was responsible for all aspects of study site monitoring including routine monitoring
and close-out of clinical sites, maintenance of study files, conduct of pre-study and
initiation visits; liaise with vendors; and other duties, as assigned
• Was responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
o Ensured the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
o Ensured the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the
applicable regulatory requirements
o Ensured the integrity of the data submitted on Case Report Forms (CRFs) or
other data collection tools by careful source document review
o Monitored data for missing or implausible data
o Ensured the resources of the Sponsor and Covance are spent wisely by
performing the required monitoring tasks in an efficient manner, according to
SOPs and established guidelines, including managing travel expenses in an
economical fashion according to Covance travel policy
4. • Prepared accurate and timely trip reports
• Was responsible for all aspects of registry management as prescribed in the project
plans
• Undertook feasibility work when requested
• Recruited potential investigators, preparation of EC submissions, notifications to
regulatory authorities, translation of study-related documentation, organization of meetings
and other tasks as instructed by supervisor
• Negotiated study budgets with potential investigators and assisted the Covance legal
department with statements of agreements as assigned
• Completed Serious Adverse Event (SAE) reporting, process production of reports,
narratives and follow up of SAEs
• Independently performed CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems as
assigned by management
• Assisted with training, mentoring, and development of new employees, e.g. co-
monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
• Performed other duties as assigned by management
Precision Therapeutics, Pittsburgh, PA, USA - Jul. 2010 – Apr. 2012
Clinical Research Associate – Jul. 2010 – Apr. 2012
• Functioned as administrator, coordinator, consultant, and educator in the management
of oncology specific clinical trials
• Ensured each site has the required staff training and materials specific to industry
standards
• Managed regulatory authority applications and approvals which oversee research of
drug response marker devices
• Acted as a Liaison with doctors and other medical disciplines on all aspects of
conducting trails
• Verified that data is consistent with patient clinical notes and/or source document
verification (SDV)
• Wrote comprehensive visit reports
5. • Cultivate skills in the administration and progress of oncology clinical trials while
understanding the ethical and legal ramifications (for all participants) covering protocol
development, data collection, analysis, monitoring, recording, auditing, ethics &
regulations, liabilities, and responsibilities of conducting research with human subjects
• Position required consummate communication skills, the importance of good clinical
practice (GCP), attention to detail, ability to build effective relationships with trial center
staff and colleagues, and a facility for motivating medical staffs
MedPace, Cincinnati, OH, USA - Aug. 2008 – Feb. 2010
Clinical Research Associate – Aug. 2008 – Feb. 2010
• Functioned as administrator, coordinator, consultant, and educator in the management
of clinical trials
• Assessed the suitability of facilities at study centers
• Ensured each site held the required staff training and materials specific to industry
standards
• Liaised with doctors and other medical disciplines on all aspects of conducting trails
• Verified that data was consistent with patient clinical notes and/or source document
verification (SDV)
• Wrote comprehensive visit reports
• Accounted for all unused trail supplies
• Closed study centers upon completion of trials
• Cultivated skills in the administration and progress of a clinical trial while
understanding the ethical and legal ramifications (for all participants) covering protocol
development, data collection, analysis, monitoring, recording, auditing, ethics &
regulations, liabilities, and responsibilities of conducting research with human subjects
• Position required consummate communication skills, importance of Good Clinical
Practice (GCP), attention to detail, ability to build effective relationships with trial center
staff and colleagues, and a facility for motivating medical staffs
6. Cornerstone BioPharma, Pittsburgh, PA, (Headquarters Cary, NC) USA – Sep. 2007 - May
2008
Pharmaceutical Sales Representative – Sep. 2007 – May 2008
• Established new territory (from ground up) for the sales/marketing of respiratory drugs
(Spectracef, Allerx and Deconsal) throughout Pittsburgh-South and parts of West Virginia
• Administered presentations to physicians encompassing clinical education/product
knowledge/scientific research on aforementioned medications
• Coordinated dinner/lunches throughout assigned territories
• Sold to pulmonologists, ENT specialists, allergy specialists, internal medicine, family
practice, pediatricians, and emergency clinics – to name a few
• Served as intermediary between company and customers
• Promoted products to more than 200 physicians within a 3-month period
• Tripled sales base within a 6-month period
• Targeted accounts based on highest potential value to the company and conducted
personal follow-up to ensure ongoing positive client relations
• Planned and implemented account development activities with focus on achieving sales
plan objectives
• Position required powerful presentation skills, account management, territory planning/
profiling, and persuasion skills for maximizing customer relationships
• Cultivated excellent interpersonal/communication skills in dealing with multiple
medical disciplines
Magee Hospital, Pittsburgh, PA, USA – May. 2006 – May. 2007
Orthopaedic Nurse – May 2006 – May 2007
• Worked with one of Pittsburgh’s foremost orthopedic surgeon in providing proficient,
age specific, professional skills in assessing, planning, implementing, and defining of
procedures up to 8 assigned patients in accordance with legal, hospital practice, and
departmental policies & procedures
• Managed the care of patients before and after surgery involving the muscular skeletal
system such as total hip replacement, arthroscopy, or total knee replacement
• Monitored traction, splint/cast care, and orthopedic equipment
• Interfaced extensively with patients, families, multi healthcare disciplines, and
administrators
7. • Provided patient/family education regarding post-op treatments and procedures
• Specific clinical duties included: medication administrations, IV therapy,
orthovac/hemovac autotransfusions/reinfusions, blood draws, hip/knee dressing changes,
positioning patients in CPM (continuous passive motion) machines, ongoing patient
assessments/evaluations, and charting
Duquesne University, Pittsburgh, PA, USA – 2002 - 2006
Job Coach – 2002 - 2006
• Taught a group of 10 mentally-challenged young adults with downs/autism/learning
disabilities
• Provided instruction and monitored various job functions performed throughout the
Duquesne University campus
• Evaluated assigned caseload on a daily basis reporting progress and/or decline of
assigned staff
Sala Chiropractic, Bethel Park, PA, USA - 2000 - 2002
Chiropractic Assistant Front Desk Operations – 2000 - 2002
• Participated in numerous public relations events with focus on new client recruitment
resulting in a significant increase of new patients
• Communicated with clients of all ages – infants to age 95
• Scheduled patients and maintained records via ChiroPlus Office Software
• Filed patient charts; responded to incoming telephone inquiries; checked patients in/out
of office; initiated appointment confirmation calls; introduced prospective clients to the
facility; completed NCRs and proscribes; labeled x-ray files; read and interpreted patient
charts for rehabilitation treatments; procured necessary insurance information
• Administered heat treatments, electric stimulation, ice treatments and professional
massages
• Adjusted rehabilitation equipment as per clients’ physical needs
• Set up mechanical traction beds
• Maintained stringent sanitation of the facility
Therapeutic Experience
• Cardiovascular: Congestive Heart Failure/Cardiac Edema/Cardiomyopathy,
Hypertension- systolic or diastolic, Hypotension
8. • Endocrine: Diabetes Mellitus / Hypoglycemia / Hyperglycemia
• Infectious Disease: Sepsis- Systemic Infections/Septic Shock
• Oncology: Breast, Colorectal, Lung - Non small cell , Ovarian, Uterine, Cervical,
Devices for Oncology, Lab Test-Assay Test
Language Capabilities
• English
Education
• B.S. Nursing, Duquesne University, Pittsburgh, PA, USA
• M.B.A. Master’s in Business Administration, Pittsburgh, PA, USA
Memberships/Awards
• Inducted into Phi Eta Sigma National Honor Society
• National Collegiate Nursing Award Nominee (United States Achievement Academy)
Other
• Computer Skills: MS Word – Excel – e-Clinical – PowerPoint – WordPerfect –
ChiroPlus