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.
The document outlines steps for designing a quality improvement program for a health care organization. It discusses creating a QI infrastructure, selecting performance measures, collecting baseline data, analyzing data to identify areas for improvement, planning and implementing changes, and monitoring performance over time. The key aspects emphasized are developing a QI plan and committee, setting SMART goals, creating a data collection process, analyzing data to choose improvement projects, implementing test changes, and sustaining improvements through ongoing measurement.
Nicole McClean is a passionate 3D modeler and rigger who has loved animated films since childhood. She has extensive experience in character rigging, especially facial rigging, as well as a strong knowledge of the entire 3D animation pipeline in Autodesk Maya and 3ds Max. Nicole has worked on numerous projects for both personal businesses and companies, including 3D logo animations, medical animations, and 3D printed models. She is skilled in rigging, modeling, texturing, and animation and has received training and awards to further develop her skills.
Nicole McClean is a passionate 3D modeller and rigger with a special interest in character rigging and facial rigging. She has a strong working knowledge of software like Autodesk Maya, 3ds Max, Zbrush, and Mudbox. Her experience includes projects at various companies involving 3D modeling, rigging, animation, and editing. She also has freelance experience and has received several awards and funding for her work.
Nicole McClean is a passionate 3D modeler and rigger who has loved animated films since childhood. She has strong skills in Autodesk Maya, 3ds Max, and other 3D software. Her special interests include character and facial rigging, and she has experience creating 3D models and animations for films, games, and installations. She is always looking for new challenges and ways to improve her skills in 3D modeling and animation.
This document contains the CV of Hany Youssef Abdelmalek Bottros, an Egyptian pensioner major general engineer. It details his personal and contact information, qualifications including a bachelor's degree in mechanical engineering, extensive experience managing factories and workshops producing automotive parts over 29 years in the armed forces, positions held, overseas missions and training, medals received, and courses completed. It provides a comprehensive overview of his career history, skills, and qualifications.
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.
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.
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.
The document outlines steps for designing a quality improvement program for a health care organization. It discusses creating a QI infrastructure, selecting performance measures, collecting baseline data, analyzing data to identify areas for improvement, planning and implementing changes, and monitoring performance over time. The key aspects emphasized are developing a QI plan and committee, setting SMART goals, creating a data collection process, analyzing data to choose improvement projects, implementing test changes, and sustaining improvements through ongoing measurement.
Nicole McClean is a passionate 3D modeler and rigger who has loved animated films since childhood. She has extensive experience in character rigging, especially facial rigging, as well as a strong knowledge of the entire 3D animation pipeline in Autodesk Maya and 3ds Max. Nicole has worked on numerous projects for both personal businesses and companies, including 3D logo animations, medical animations, and 3D printed models. She is skilled in rigging, modeling, texturing, and animation and has received training and awards to further develop her skills.
Nicole McClean is a passionate 3D modeller and rigger with a special interest in character rigging and facial rigging. She has a strong working knowledge of software like Autodesk Maya, 3ds Max, Zbrush, and Mudbox. Her experience includes projects at various companies involving 3D modeling, rigging, animation, and editing. She also has freelance experience and has received several awards and funding for her work.
Nicole McClean is a passionate 3D modeler and rigger who has loved animated films since childhood. She has strong skills in Autodesk Maya, 3ds Max, and other 3D software. Her special interests include character and facial rigging, and she has experience creating 3D models and animations for films, games, and installations. She is always looking for new challenges and ways to improve her skills in 3D modeling and animation.
This document contains the CV of Hany Youssef Abdelmalek Bottros, an Egyptian pensioner major general engineer. It details his personal and contact information, qualifications including a bachelor's degree in mechanical engineering, extensive experience managing factories and workshops producing automotive parts over 29 years in the armed forces, positions held, overseas missions and training, medals received, and courses completed. It provides a comprehensive overview of his career history, skills, and qualifications.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Emily Angevine has over 10 years of experience in clinical research. She holds a B.S. in Recreational Therapy and has advanced through roles at PPD from Project Assistant to her current role as Senior Country Approval Specialist. She prepares, reviews, and coordinates local regulatory submissions and develops submission strategies. Previously she coordinated administrative functions and ensured regulatory compliance as a Principal Project Assistant, Senior Project Assistant, and Project Assistant II.
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.
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 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.
Kamala M. has over 15 years of experience in clinical research project management and operations. She has worked for several large pharmaceutical companies conducting all phases of clinical trials. Her experience includes protocol development, site selection and management, patient recruitment, regulatory documentation, clinical data management, and interacting with stakeholders. She is proficient in various clinical research databases and systems.
CTC Resourcing Solutions is a European staffing agency providing flexible resourcing to the pharmaceutical industry, including clinical development, data management, and regulatory affairs roles. They are seeking a Clinical Study Manager for a 6-month contract with a UK pharmaceutical client. The role involves managing ongoing oncology studies in Europe, ensuring delivery according to regulations and timelines while overseeing contract research organizations. Qualified candidates will have a science degree, 3-5 years of clinical research experience preferably including time as a clinical research associate, and skills in relationship building, influencing, and managing vendors.
Tywiana Smallwood has over 20 years of experience in customer service, clinical research, and healthcare. She currently works as a Senior Patient Care Advocate at United BioSource Corporation, where she manages clinical research programs and ensures compliance. Previously, she held roles in patient advocacy, quality assurance, and medical office administration. She has strong communication, organizational, and problem-solving skills.
Jwana RashadAbdelwahab is an Egyptian citizen born in 1985 who has worked in several medical and laboratory roles. She received a Bachelor's Degree in Applied Medicine from October Six University in 2007, specializing in pathology. Her work experience includes positions as a Senior Medical Network Operations professional at Al-Ahly Medical Company, a Senior International Account Advisor for Vodafone UK, a Senior Assistant Medical Director at Cairo Labs, a Medical Laboratory Manager, and an Assistant Lecturer at October Six University. She has strong computer, research, and language skills and enjoys reading, walking, chess, and drawing in her free time.
Jeremy Fernandez has over 10 years of experience in clinical research and data analysis. He currently works as a Regional Manager and Data Scientist for the Colorado Cancer Research Program, where he performs data analysis on large datasets, identifies trends, and presents findings. Previously he has held positions as a Clinical Research Associate, Data Coordinator, and Clinical Trials Coordinator for various studies. He has extensive experience ensuring regulatory compliance and has developed training programs and standard operating procedures.
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.
James Harrison is a dynamic and focused QA Officer seeking to further develop his skills. He has over 8 years of experience in QA roles, currently serving as QA Officer at BTG Prudhoe where he manages quality systems and processes. His responsibilities include quality management, auditing, process improvement, and ensuring regulatory compliance. He has a Masters in Biomedical Science and is a trained and certified biomedical scientist.
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.
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.
MONITORING VISIT INVESTIGATIONAL PRODUCT
CLINICAL RESEARCH
M.PHARMACY
PHARMACY PRACTICE
IST YEAR
The act of overseeing the progress of a clinical trial, and of ensuring that is conducted, recorded and reported in accordance with the
Protocol
Standard Operating Procedures (SOPs)
Good Clinical Practice (GCP)
Applicable regulatory requirements
It is an ongoing process conducted before, during and after the trial.
MONITOR
A designee of the sponsor who is assigned the task of monitoring the study.
CLINICAL RESEARCH ASSOCIATE
A monitor in a clinical trial is also called a CRA – Clinical Research Associate
CRA is a sponsor representative conducts the clinical trial monitoring by visiting the clinical trial site at frequent intervals.
CRA is responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations and Good Clinical Practice.
Acts as main line of communication between sponsor and the investigator.
The CRA will be involved in all stages of the clinical trial including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
ROLES AND RESPONSIBILITIES OF MONITOR(CRA)
To verify
Investigator qualifications
Facilities including laboratories, equipment and staff are adequate
Investigator follows the approved protocol
Written informed consent was obtained before each subject's participation in the trial
Investigator is enrolling only eligible subjects
All adverse events are appropriately reported within the time period
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
TYPES OF MONITORING VISITS
1.SITE SELECTION VISIT
A site selection visit means that a CRA goes to visit a certain site before it can be awarded a study.
It is a 1-day visit.
When sites look for potential studies, they email or fax the sponsor with their presentation of the site and their interest in the study.
If the sponsor is interested, he will send a CDA (Confidential disclosure agreement) to sign.
The site that’s interested in conducting a certain study will first fill out a Feasibility survey which the sponsor will review.
2.SITE INITIATION VISIT
Site initiation visit happens after the site has been selected, the terms and budget have been negotiated, and all the documents have been signed.
It takes a 2-day visit.
It focuses on preparation and training the clinical trial site to conduct the study.
It is conducted prior to subject/ patient recruitment.
Contrary to the first type, these visits do require that the CRA has more knowledge and
understands the protocol in-depth.
3.ROUTINE MONITORING/INTERIM MONITORING VISITS
Routine monitoring visit is a mandatory and frequent visit that occurs every 4 to 6 weeks depending on the site’s enrollment volume.
4.SITE CLOSE-OUT VISIT
The close-out visit takes place when the study has already finished.
A study can end for various reasons
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.
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.
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.
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.
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.
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.
Emily Angevine has over 10 years of experience in clinical research. She holds a B.S. in Recreational Therapy and has advanced through roles at PPD from Project Assistant to her current role as Senior Country Approval Specialist. She prepares, reviews, and coordinates local regulatory submissions and develops submission strategies. Previously she coordinated administrative functions and ensured regulatory compliance as a Principal Project Assistant, Senior Project Assistant, and Project Assistant II.
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.
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 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.
Kamala M. has over 15 years of experience in clinical research project management and operations. She has worked for several large pharmaceutical companies conducting all phases of clinical trials. Her experience includes protocol development, site selection and management, patient recruitment, regulatory documentation, clinical data management, and interacting with stakeholders. She is proficient in various clinical research databases and systems.
CTC Resourcing Solutions is a European staffing agency providing flexible resourcing to the pharmaceutical industry, including clinical development, data management, and regulatory affairs roles. They are seeking a Clinical Study Manager for a 6-month contract with a UK pharmaceutical client. The role involves managing ongoing oncology studies in Europe, ensuring delivery according to regulations and timelines while overseeing contract research organizations. Qualified candidates will have a science degree, 3-5 years of clinical research experience preferably including time as a clinical research associate, and skills in relationship building, influencing, and managing vendors.
Tywiana Smallwood has over 20 years of experience in customer service, clinical research, and healthcare. She currently works as a Senior Patient Care Advocate at United BioSource Corporation, where she manages clinical research programs and ensures compliance. Previously, she held roles in patient advocacy, quality assurance, and medical office administration. She has strong communication, organizational, and problem-solving skills.
Jwana RashadAbdelwahab is an Egyptian citizen born in 1985 who has worked in several medical and laboratory roles. She received a Bachelor's Degree in Applied Medicine from October Six University in 2007, specializing in pathology. Her work experience includes positions as a Senior Medical Network Operations professional at Al-Ahly Medical Company, a Senior International Account Advisor for Vodafone UK, a Senior Assistant Medical Director at Cairo Labs, a Medical Laboratory Manager, and an Assistant Lecturer at October Six University. She has strong computer, research, and language skills and enjoys reading, walking, chess, and drawing in her free time.
Jeremy Fernandez has over 10 years of experience in clinical research and data analysis. He currently works as a Regional Manager and Data Scientist for the Colorado Cancer Research Program, where he performs data analysis on large datasets, identifies trends, and presents findings. Previously he has held positions as a Clinical Research Associate, Data Coordinator, and Clinical Trials Coordinator for various studies. He has extensive experience ensuring regulatory compliance and has developed training programs and standard operating procedures.
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.
James Harrison is a dynamic and focused QA Officer seeking to further develop his skills. He has over 8 years of experience in QA roles, currently serving as QA Officer at BTG Prudhoe where he manages quality systems and processes. His responsibilities include quality management, auditing, process improvement, and ensuring regulatory compliance. He has a Masters in Biomedical Science and is a trained and certified biomedical scientist.
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.
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.
MONITORING VISIT INVESTIGATIONAL PRODUCT
CLINICAL RESEARCH
M.PHARMACY
PHARMACY PRACTICE
IST YEAR
The act of overseeing the progress of a clinical trial, and of ensuring that is conducted, recorded and reported in accordance with the
Protocol
Standard Operating Procedures (SOPs)
Good Clinical Practice (GCP)
Applicable regulatory requirements
It is an ongoing process conducted before, during and after the trial.
MONITOR
A designee of the sponsor who is assigned the task of monitoring the study.
CLINICAL RESEARCH ASSOCIATE
A monitor in a clinical trial is also called a CRA – Clinical Research Associate
CRA is a sponsor representative conducts the clinical trial monitoring by visiting the clinical trial site at frequent intervals.
CRA is responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations and Good Clinical Practice.
Acts as main line of communication between sponsor and the investigator.
The CRA will be involved in all stages of the clinical trial including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
ROLES AND RESPONSIBILITIES OF MONITOR(CRA)
To verify
Investigator qualifications
Facilities including laboratories, equipment and staff are adequate
Investigator follows the approved protocol
Written informed consent was obtained before each subject's participation in the trial
Investigator is enrolling only eligible subjects
All adverse events are appropriately reported within the time period
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
TYPES OF MONITORING VISITS
1.SITE SELECTION VISIT
A site selection visit means that a CRA goes to visit a certain site before it can be awarded a study.
It is a 1-day visit.
When sites look for potential studies, they email or fax the sponsor with their presentation of the site and their interest in the study.
If the sponsor is interested, he will send a CDA (Confidential disclosure agreement) to sign.
The site that’s interested in conducting a certain study will first fill out a Feasibility survey which the sponsor will review.
2.SITE INITIATION VISIT
Site initiation visit happens after the site has been selected, the terms and budget have been negotiated, and all the documents have been signed.
It takes a 2-day visit.
It focuses on preparation and training the clinical trial site to conduct the study.
It is conducted prior to subject/ patient recruitment.
Contrary to the first type, these visits do require that the CRA has more knowledge and
understands the protocol in-depth.
3.ROUTINE MONITORING/INTERIM MONITORING VISITS
Routine monitoring visit is a mandatory and frequent visit that occurs every 4 to 6 weeks depending on the site’s enrollment volume.
4.SITE CLOSE-OUT VISIT
The close-out visit takes place when the study has already finished.
A study can end for various reasons
1. CURRICULUM VITAE
Masood M Khan, B.Sc., MD
1200 West Sturbridge Drive, Hoffman Estates, IL 60192
Cell-847-977-2211
janozai@hotmail.com
CAREER HIGHLIGHTS
THERAPEUTIC EXPERIENCE
Page 1 of 9
Years in the Industry: 13 years in the clinical research industry in Oncology,
Gastrointestinal, Cardiovascular, Hematology, Genetics, Nephrology, Neurology and
Immunology indications and medical experience as a Medical Doctor and General
Surgeon in India.
CRA Experience: 13 years of CRA experience
Industry Experience: Experienced in CRO side of the industry
Supervisory/Mentoring/ Training Experience: Trainer for any study as a Visit Leader
and trained new employees in medical terminology at former job.
Clinical Experience: 7 years experience working as an MD in India and as a general
Surgeon in ER and Trauma centers.
Additional Valuable Experience: Experience with site feasibility, site
selection/initiation/monitoring/close-out visits, study metrics tracking, EDC (Rave)
2. Masood M Khan, B.Sc., MD
Updated 09Sep2016
EDUCATION
MD, March 1992
Deccan College of Medical Sciences, Hyderabad, India
Degree received thru Osmania University
B.Sc, March 1987
Anwar-Ul-Uloom College, Hyderabad, India
EMPLOYMENT
United BioSource Corporation
Blue Bell, PA
Senior Clinical Research Associate (Sr. CRA)
February 2016 - Present
Page 2 of 9
Oncology Neurology
Breast--Phase III MS – Phase II
Ovarian – Phase III AD – Phase III
NSCLC – Phase III
Melanoma—Phase 1b/II
Prostate – Phase III Genetics
Bladder– Phase III PKU–Phase II/III
Colorectal – Phase II/III ACH-Phase I/II
Multiple Myeloma—Phase II
Haematology Immunology -RA, Psoriasis, SpA-–Phase II/III
Anemia – Phase II
Gastrointestinal Nephrology-CKD-–Phase III
IBS study– Phase II/III
Cardiovascular Device--Breast Implant Follow-up Study Phase IV
Hypercholesterolemia– Phase II
Hypertension– Phase II/III
Heart Failure and Left Ventricular Systolic
Dysfunction – Phase II
Acute decompensated heart
Failure (ADHF)-Phase IIIb/IV
3. Masood M Khan, B.Sc., MD
Updated 09Sep2016
• Thorough knowledge and application of project specific protocol
• Consistently completes on site monitoring in accordance with project specific timelines
• Consistently completes travel scheduling in accordance with project specific and UBC guidelines
• Attends project team meetings, department meetings and minimum of monthly 1:1 with manager;
responsible for content of these meetings
• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or
client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to
UBC and/or sponsor timelines requiring minimal corrections
• Ensures follow-up of site issues and action items per UBC/sponsor timelines
• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
• Ensures completion of Call Log or Telephone Contact Report detailing communication with sites
per protocol
• Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
• Completes Regulatory Binder and Investigational Product reconciliation
• Maintains regular contact with assigned sites per study requirements
• Consistently submits expense reports within UBC timelines; consistently follows UBC Travel
Guidelines
• Consistently completes SOP review and documentation within requested timelines
• Consistently completes sponsor specific training and documentation within requested timelines
• Assists PM and management team by being an AIM leader, upon receipt of AIM training
• A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s
ability to perform visit type independently
• I = Instruct how to conduct visit, report/letter writing and manage issues and actions
• M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
• Assists management team by mentoring other CRAs
• Assists with preparation and/or delivery of presentations for UBC Academy, departmental training
and/or sponsor specific training
Quintiles
Regional: Chicago, Illinois
Sr. CRA 3
September 2014 to 10Feb2016
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (up to 80%
travel) for GCP compliance according to SOPs and/or client guidelines
o Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits. Visits
to include monitoring of proper informed consent procedures, compliance with protocol,
GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site
performance.
Page 3 of 9
4. Masood M Khan, B.Sc., MD
Updated 09Sep2016
o Document each visit with a quality written monitoring visit report and submit to the reviewer
for review and approval within contractual guidelines
o Author and send follow up letter to investigative site documenting the visit and any outstanding
items to be addressed within contractual timelines.
o Review and approve monitoring visits reports ensuring finalization within contractual
obligations
o Assist Project Managers in study execution by acting as Lead CRA on projects and facilitating
communication with Clinical Monitoring team
o Perform monitoring evaluation visits with CRAs
o Develop and facilitate training for colleagues on clinical, regulatory, administrative, and
company procedures and processes
o Develop study specific tools for tracking and reporting for Clinical Monitoring team
o Participate in feasibility studies
o Develop and write Clinical Monitoring Plans
o Present study materials at Investigator/study launch meetings with required
o Support project management team with assessment of workload and site assignments within the
project team
o Assist project management team with review of monitoring reports and study documents with
required
o Participate in company-required training programs
o Participate on BID defense meetings
o Perform necessary administrative functions (e.g. submission of expense reports, entering time).
o Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
o Perform regulatory activities, if applicable
InVentiv Health Clinical
Regional: Chicago, Illinois
Senior Site Manager
February 2014 to September 2014
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (up to 80%
travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines
o Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits. Visits
to include monitoring of proper informed consent procedures, compliance with protocol,
GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site
performance.
o Document each visit with a quality written monitoring visit report and submit to the reviewer
for review and approval within contractual guidelines
o Author and send follow up letter to investigative site documenting the visit and any outstanding
items to be addressed within contractual timelines.
Page 4 of 9
5. Masood M Khan, B.Sc., MD
Updated 09Sep2016
o Review and approve monitoring visits reports ensuring finalization within contractual
obligations
o Assist Project Managers in study execution by acting as Lead CRA on projects and facilitating
communication with Clinical Monitoring team
o Perform monitoring evaluation visits with CRAs
o Develop and facilitate training for colleagues on clinical, regulatory, administrative, and
company procedures and processes
o Develop study specific tools for tracking and reporting for Clinical Monitoring team
o Participate in feasibility studies
o Develop and write Clinical Monitoring Plans
o Present study materials at Investigator/study launch meetings with required
o Support project management team with assessment of workload and site assignments within the
project team
o Assist project management team with review of monitoring reports and study documents with
required
o Participate in company-required training programs
o Participate on BID defense meetings
o Perform necessary administrative functions (e.g. submission of expense reports, entering time).
o Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
o Perform regulatory activities, if applicable
ReSearch Pharmaceutical Services, Inc.,
Fort Washington, PA
Senior Site Manager
June 2010 to February 2014
Responsible for monitoring of study sites, as laid out in ICH/GCP Chapter 5.18 ‘Monitoring’. Duties
and Responsibilities (including but not limited to):
o Adhere with corporate internal polices and requirements, including submission of timesheets
and expense reports in a timely manner.
o Conduct study feasibility and site selection activities
o Develop and implement innovative approaches for and participates in site recruitment, selection
and initiation activities.
o Assist with investigator meeting activities including organization, preparation and attendance
o Conduct site management activities including but not limited to site selection visits, site
initiation visits, site training, site routine monitoring visits, and site close out visits.
o Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and
company guidelines.
o Establish and maintain good rapport with study sites.
Page 5 of 9
6. Masood M Khan, B.Sc., MD
Updated 09Sep2016
o Write study visit reports and follow up letters within the timeline established by applicable
SOPs and guidelines
o Representation of CRAs during an audit or inspection when assigned
o Coordinate timely shipment of clinical supplies and study drug to sites.
o Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
o Maintain adequate site tracking records
o Follow up of drug safety issues and safety reports in timely manner, if applicable
o Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead
and Clinical Research Manager accordingly
o Develop and implementation of corrective actions when appropriate
o Assist with data query form (incl. query process)
o Prepare /review all patients tracking records
o Input and maintain study information concerning subject status of financial reimbursement to
sites.
o Conduct and assist with administrative activities as a member of the project team.
PRA International
Regional: Chicago, Illinois
Sr. Clinical Research Associate
February, 2007-June, 2010
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being
met and are compliant with applicable local regulatory requirements and ICH guidelines
O Visits sites to assess the qualification of potential investigative sites, initiate studies,
instruct site personnel on the proper conduct of studies, to review data and ensure
accuracy of data collected and to terminate studies
O Provides regular clinical status information to team members and project management
O Performs billable work in accordance with company policies, procedures, and Standard
Operating Procedures (SOPs)
O Works closely with other team members to ensure timely resolution of project and/or
clinical issues and obtains direction from more senior clinical operations staff
O Communicates common site trends to Lead CRA and other project team members
• Performs investigative site file reconciliation; requests any new or updated site-related essential
and non-essential documents and reviews them for content, consistency with other documents, and
compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and
sponsor requirements
O Performs source document verification, retrieves Case Report Forms (CRFs) and
performs query resolution in a timely manner and oversees drug accountability and
safety at investigative sites
O Ensures Serious Adverse Event (SAE) reporting according to project specifications
O Responds to requests from investigative sites in a timely fashion
Page 6 of 9
7. Masood M Khan, B.Sc., MD
Updated 09Sep2016
• May serve as a resource for and interact with other functional areas to resolve site issues and
facilitate project timelines
• Assisted as SWAT CRA in resolution of outstanding DCFs (Queries). And collected case report
forms. Performed COVs, and motivational visits for non-enrolling sites.
• Mentor to new CRA’s and as a Visit Leader. (Trained and evaluate CRAs of all levels on all visit
types)
• Assisted Functional Manager with administrative duties as required
• Identifies processes/contractual obligations creating obstacles to timely and accurate completion of
monitoring activities, proposes solutions to LCRA/PM/FM
• Identify and resolve complex monitoring issues.
PRA International
Regional: Chicago, Illinois
Clinical Research Associate II
May, 2006-February, 2007
• Managed the activities of clinical investigative sites across multiple protocols and multiple
therapeutic areas with the ability to manage, with minimal supervision, sites participating in more
complex clinical studies and/or sites requiring more oversight of operational issues.
• Managed the overall activities of site personnel over whom there is no direct authority and
motivate/influence them to meet study objectives.
• Ensured quality of data submitted from study sites and assures timely submission of data, including
appropriate reporting and follow-up for all safety events by site personnel.
• Ensured safety and protection of study subjects according to the monitoring plan, SOPs, ICH
Guidelines, and federal regulations.
• Train study site personnel on the protocol and applicable regulatory requirements in collaboration
with pertinent project team members.
• Appropriately escalate serious or outstanding issues to senior level CRA/Regional Manager (RM)
or the appropriate project team member(s).
• Facilitate Quality Assurance Audit processes as indicated.
• Ensured regulatory inspection readiness at assigned clinical sites.
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit
written reports, both monitoring and administrative, in a timely, concise and objective manner.
• Participate in field training and mentoring of new/junior CRAs. May provide input relative to
performance review and development opportunities.
• Identify, evaluate and recommend new/potential investigators/sites on an on-going basis.
PRA International
Regional: Chicago, Illinois
Clinical Research Associate I
May, 2005-May, 2006
• Participated in identification of potential qualified investigators and clinical sites as required,
Page 7 of 9
8. Masood M Khan, B.Sc., MD
Updated 09Sep2016
including contacting potential investigators and conducting pre-study site visits; assist in the
collection, review and tracking of essential pre-study documents as required.
• Conducted all activities in accordance with ICH, GCP, PRA SOPs and applicable country
regulations and all assigned trials in accordance with contractual timelines and specific project
team requirements
• Conducted routine monitoring visits in a way which efficiently supports the site throughout its
participation in a trial and to provide feedback on site performance and develop resolution plans
with LCRA/PM assistance
• Demonstrated ability to work independently and as team member prioritizes and completes tasks as
required and to perform drug accountability at investigator sites
• Demonstrates an ability to review and report outstanding site issues to Project Manager or Lead
CRA in a way that facilitates resolution and reviewed CRF to ensure it is complete and accurate
• Reviewed regulatory documents to ensure accuracy and completeness and has complete
understanding of the project protocol and a good understanding of the relevant therapeutic area
• Performed Investigative site file reconciliation, source document verification to sponsor
expectations and reported investigative site status in a way that facilitates accurate and efficient
trial conduct
ICON Clinical Research, Inc
Deerfield, Illinois
Clinical Research Associate I
August, 2003-February, 2005
• Monitored phase II/III Oncology, Gastrointestinal and Cardiovascular studies in Canada,
Australia, Singapore and the USA
• Presented at investigator’s meetings; assisted in site selection; performed site initiation,
monitoring, close out and co-monitoring visits
• Prepared for sponsor and FDA audits; mentored and trained study coordinators and Clinical
Research Associate colleagues.
• Managed time, expenses and visit frequency per study guidelines.
• Assisted in the resolution of data queries.
• Assisted with follow-up of adverse events (AEs) and serious adverse events (SAEs) as necessary;
reconcile SAEs with the clinical data (CRF/RDE).
• Communicated with study sites to ensure that all clinical aspects of the trial are adhered to in
accordance with the protocol and Sponsor directives as well as state and federal regulations,
guidelines and/or policies; provide on-going instruction to research site personnel, as necessary, on
proper conduct of the trial. Ensure timely and proper completion of data by assigned clinical sites.
• Prepared comprehensive and detailed reports documenting study status, site issues and monitoring
activities within specified timeframes.
Computer literacy: Proficiency in MS Office, eCRF/Electronic Data Capture: (Medidata) RAVE,
Page 8 of 9
9. Masood M Khan, B.Sc., MD
Updated 09Sep2016
iMedidata, UBC Track, UBC Capture 2.0, Siebel/CTMS; Data Labs, ClinPhone, IXRS and IVRS.
LANGUAGES
English
Urdu, Hindi (Indian languages)—fluent
Arabic, Farsi, Pashtu (Dari)--basic
PRESENTATIONS
“Hypertension and Hypercholesterolemia” indications for Cardiovascular study 2004 at
Investigator meeting
JOB TITLE HISTORY
Clinical Research Associate, Level III, June 2010 to present
Clinical Research Associate, Level III, February 2007 to June 2010
Clinical Research Associate, Level II, May 2006 to February 2007
Clinical Research Associate, Level I, May 2005 to May 2006
Clinical Research Associate, Level I, August, 2003-February, 2005
Page 9 of 9
10. Masood M Khan, B.Sc., MD
Updated 09Sep2016
iMedidata, UBC Track, UBC Capture 2.0, Siebel/CTMS; Data Labs, ClinPhone, IXRS and IVRS.
LANGUAGES
English
Urdu, Hindi (Indian languages)—fluent
Arabic, Farsi, Pashtu (Dari)--basic
PRESENTATIONS
“Hypertension and Hypercholesterolemia” indications for Cardiovascular study 2004 at
Investigator meeting
JOB TITLE HISTORY
Clinical Research Associate, Level III, June 2010 to present
Clinical Research Associate, Level III, February 2007 to June 2010
Clinical Research Associate, Level II, May 2006 to February 2007
Clinical Research Associate, Level I, May 2005 to May 2006
Clinical Research Associate, Level I, August, 2003-February, 2005
Page 9 of 9