Nancy MacDonald has over 11 years of experience in clinical trial administration. She has extensive experience managing clinical trials and ensuring compliance with regulations. Her skills include clinical trial coordination, document management, training junior staff, and acting as a liaison between study teams and clients. She is proficient in common software programs and clinical trial management systems.
This curriculum vitae is for Valerie Watson, who has over 15 years of experience in clinical research coordination and administration. She is currently a Clinical Research Coordinator at Danbury Hospital, where her responsibilities include patient recruitment, protocol implementation, data collection, and ensuring regulatory compliance. Previously, she held roles as an Administrative Assistant/Clinical Research Coordinator and Medical Assistant/Secretary. Valerie has a Bachelor's degree in Biology from Western Connecticut State University and maintains several professional certifications. She has extensive training in good clinical practice and regulatory guidelines.
This document provides a summary of a highly experienced office manager. It includes contact information and an overview of employment history managing administrative teams in the healthcare sector over the past 15 years. Key responsibilities have involved leading teams, implementing standard operating procedures, managing budgets, and supporting new computer system rollouts. Relevant qualifications and training are also listed.
Whitney Knight is seeking a position in clinical research to utilize experience in clinical trial monitoring, quality assurance, and FDA regulations. She has over 5 years of experience as a Clinical Research Associate and Clinical Trials Assistant conducting monitoring visits, building relationships with investigators, training site staff, and ensuring protocol and regulatory compliance. She has therapeutic expertise in oncology and rheumatoid arthritis from her involvement in clinical trials in these areas.
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.
Melissa Kimble is an experienced healthcare management professional seeking a new opportunity. She has over 15 years of experience managing clinical divisions and staff at major hospitals like Brigham and Women's Hospital. Her background includes overseeing budgets, scheduling, training, and ensuring compliance. She is proficient in various medical software and has a track record of improving processes, productivity and patient satisfaction.
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.
This document is a resume for Matthew R. Delamar summarizing his experience and qualifications as a medical/nursing assistant. Over his career, Delamar has gained experience in roles such as optometry technician, vital signs technician, administration clerk, acute care technician, and sick call assistant while serving in the military at various medical facilities including the New London Sub Base in Groton, CT and the Marine Corps Recruit Depot in Parris Island, SC. His resume highlights his skills in areas like documentation, administration, patient care, and training/supervising other medical personnel.
Chris Bowerman seeks a position and has extensive experience as a gastroenterology technician, clinical consultant, anesthesia technician, and airborne infantryman. He has assisted with procedures, maintained equipment, educated staff, and implemented electronic medical record systems at various medical centers and hospitals in North Carolina, Texas, Nevada, and the U.S. Army. Bowerman is nationally certified, pursing several degrees, and was awarded various honors for his performance.
This curriculum vitae is for Valerie Watson, who has over 15 years of experience in clinical research coordination and administration. She is currently a Clinical Research Coordinator at Danbury Hospital, where her responsibilities include patient recruitment, protocol implementation, data collection, and ensuring regulatory compliance. Previously, she held roles as an Administrative Assistant/Clinical Research Coordinator and Medical Assistant/Secretary. Valerie has a Bachelor's degree in Biology from Western Connecticut State University and maintains several professional certifications. She has extensive training in good clinical practice and regulatory guidelines.
This document provides a summary of a highly experienced office manager. It includes contact information and an overview of employment history managing administrative teams in the healthcare sector over the past 15 years. Key responsibilities have involved leading teams, implementing standard operating procedures, managing budgets, and supporting new computer system rollouts. Relevant qualifications and training are also listed.
Whitney Knight is seeking a position in clinical research to utilize experience in clinical trial monitoring, quality assurance, and FDA regulations. She has over 5 years of experience as a Clinical Research Associate and Clinical Trials Assistant conducting monitoring visits, building relationships with investigators, training site staff, and ensuring protocol and regulatory compliance. She has therapeutic expertise in oncology and rheumatoid arthritis from her involvement in clinical trials in these areas.
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.
Melissa Kimble is an experienced healthcare management professional seeking a new opportunity. She has over 15 years of experience managing clinical divisions and staff at major hospitals like Brigham and Women's Hospital. Her background includes overseeing budgets, scheduling, training, and ensuring compliance. She is proficient in various medical software and has a track record of improving processes, productivity and patient satisfaction.
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.
This document is a resume for Matthew R. Delamar summarizing his experience and qualifications as a medical/nursing assistant. Over his career, Delamar has gained experience in roles such as optometry technician, vital signs technician, administration clerk, acute care technician, and sick call assistant while serving in the military at various medical facilities including the New London Sub Base in Groton, CT and the Marine Corps Recruit Depot in Parris Island, SC. His resume highlights his skills in areas like documentation, administration, patient care, and training/supervising other medical personnel.
Chris Bowerman seeks a position and has extensive experience as a gastroenterology technician, clinical consultant, anesthesia technician, and airborne infantryman. He has assisted with procedures, maintained equipment, educated staff, and implemented electronic medical record systems at various medical centers and hospitals in North Carolina, Texas, Nevada, and the U.S. Army. Bowerman is nationally certified, pursing several degrees, and was awarded various honors for his performance.
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 is a summary of Karen Knight's resume:
Karen Knight has over 33 years of experience in healthcare, including roles as a clinical RN, perioperative manager, healthcare educator, and construction project manager. She has extensive experience managing multi-disciplinary healthcare teams and optimizing technology and workflows. Her most recent role was as Project Manager for the construction of a new 112-bed hospital, which was completed on time and under budget.
Pamela J. Pedron has over 15 years of experience in healthcare leadership roles, with a proven track record of optimizing employee, physician, and patient satisfaction. She has led multiple departments across several healthcare facilities, improving key metrics like reducing infection rates by 27% and falls by 45%. Currently serving as Chief Clinical Officer, she continues developing staff and initiating organizational change to promote optimal patient outcomes.
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.
- Gabrielle Evans seeks a leadership or management role with over 20 years of experience in medical administration, including 5 years supervising teams of up to 20 staff. She has experience scheduling appointments, training staff, and ensuring compliance with clinical standards.
Roger Hutson is a clinical research professional with over 20 years of experience in project leadership and management. He has extensive experience conducting all phases of clinical trials in various therapeutic areas, including oncology, neurology, and infectious diseases. His background includes roles as a senior clinical research associate, clinical team leader, budget compliance officer, and clinical research consultant.
Patricia Baxter is an experienced interim director of perioperative services with over 15 years of experience managing operating rooms, post-anesthesia care units, and endoscopy suites. She has worked in both non-profit and for-profit hospitals, and specializes in transitional management and cost containment. Her experience includes responsibilities such as budget preparation, staff supervision, quality improvement initiatives, and maintaining compliance with regulatory standards.
Darryl Henderson has over 10 years of experience in sterile processing and central supply roles. As Central Sterile Manager, he would manage staff and resources to maximize productivity, cost effectiveness, and ensure high quality patient care. He has a track record of implementing policies and procedures to maintain compliance with regulatory standards.
Nancy Hudson has over 20 years of experience in office operations, human resources, and healthcare administration. She most recently served as the Office Coordinator for Beebe Internal Medicine, where she managed the daily operations of a busy medical practice. Prior to that, she spent 10 years in various roles, including Practice Administrator and Practice Manager, at St. Helena Hospital, where she oversaw multiple physician practices, coordinated the opening of new offices, and improved operational processes. She also has experience as an Office Operations Manager at Deloitte, where she directed office administration and infrastructure.
Kimberly K Kenney is seeking a position in the medical field where she can utilize over 20 years of experience as an office manager and medical assistant. She currently works as the office manager and lead medical assistant for Dr. John and Dr. Justine Gelinas' OB-GYN practice, where she oversees all clinical and office operations. Her experience also includes roles as a medical assistant for other medical practices. She has extensive skills in clinical procedures, office management, billing, and training/supervising staff. She aims to apply her strong organizational, problem-solving, and communication skills to benefit a successful medical practice.
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.
The document is a resume for Cristina Schrimp applying for a Nuclear Medicine Supervisor position. She has over 15 years of experience in various medical roles including as a Nuclear Medicine and PET/CT Technologist, MRI Coordinator, and Healthcare Screener. Her skills include workflow optimization, attention to detail, problem solving, teamwork, customer service, and leadership. She is certified in nuclear medicine and has operated various medical imaging equipment while adhering to safety procedures. She is currently pursuing an MBA and has a background in healthcare management.
Nathan Malone is seeking a challenging and fast-paced opportunity to use his skills and experience in clinic management, EMR training, and operational communications. He has over 10 years of experience in these areas, currently working as a Practice Administrator for the Heart Institute of Colorado. Prior to that, he held various roles at INTEGRIS CARDIOVASCULAR PHYSICIANS including Epic Credentialed Trainer, HIM Manager, Communication & Training Manager, and Clinic Manager. He is pursuing an MBA in Health Care Administration from Southern Nazarene University.
Marie-Noëlle Debelle's curriculum vitae outlines her educational background including a Master's in Biology from the Catholic University of Louvain and over 30 years of experience in the pharmaceutical industry, primarily at GlaxoSmithKline Biologicals where she has held several senior management roles focused on quality, risk management, and regulatory affairs.
Jesse Mitsch has over 20 years of experience in clinical operations management, medical supply logistics, and surgical assistance. He has a background in the military as a clinical operations manager, where he oversaw medical department operations and a staff of 20. He currently works as a surgical technician assisting with minimally invasive spine surgeries. Mitsch has extensive leadership experience managing medical teams and ensuring quality patient care. He also has expertise in medical equipment, inventory management, and vendor relationships.
This document describes the development of modules to improve productivity in endoscopy units. It outlines several new and revised modules that were created, which focus on areas like referral management, patient experience, and pre-assessment. The modules were tested by teams at various hospital sites. Measures were also developed to track performance across domains like quality, staff morale, timeliness and cost. Feedback from medical professionals highlighted how the modules helped standardize processes, reduce delays and improve communication to enhance the patient experience. The overall goal was to create a comprehensive guide for optimizing endoscopy unit operations.
This document summarizes the professional experience of Filbert John Aquino as a healthcare administrator and surgical assistant. He has over 20 years of experience in roles such as administrator of the Warm Springs Surgery Center, surgical first assistant at St. Rose Delima hospital, and manager of the Las Vegas Surgery Center. His experiences demonstrate skills in management, operations, quality improvement, and assisting physicians with surgeries.
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.
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.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
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 is a summary of Karen Knight's resume:
Karen Knight has over 33 years of experience in healthcare, including roles as a clinical RN, perioperative manager, healthcare educator, and construction project manager. She has extensive experience managing multi-disciplinary healthcare teams and optimizing technology and workflows. Her most recent role was as Project Manager for the construction of a new 112-bed hospital, which was completed on time and under budget.
Pamela J. Pedron has over 15 years of experience in healthcare leadership roles, with a proven track record of optimizing employee, physician, and patient satisfaction. She has led multiple departments across several healthcare facilities, improving key metrics like reducing infection rates by 27% and falls by 45%. Currently serving as Chief Clinical Officer, she continues developing staff and initiating organizational change to promote optimal patient outcomes.
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.
- Gabrielle Evans seeks a leadership or management role with over 20 years of experience in medical administration, including 5 years supervising teams of up to 20 staff. She has experience scheduling appointments, training staff, and ensuring compliance with clinical standards.
Roger Hutson is a clinical research professional with over 20 years of experience in project leadership and management. He has extensive experience conducting all phases of clinical trials in various therapeutic areas, including oncology, neurology, and infectious diseases. His background includes roles as a senior clinical research associate, clinical team leader, budget compliance officer, and clinical research consultant.
Patricia Baxter is an experienced interim director of perioperative services with over 15 years of experience managing operating rooms, post-anesthesia care units, and endoscopy suites. She has worked in both non-profit and for-profit hospitals, and specializes in transitional management and cost containment. Her experience includes responsibilities such as budget preparation, staff supervision, quality improvement initiatives, and maintaining compliance with regulatory standards.
Darryl Henderson has over 10 years of experience in sterile processing and central supply roles. As Central Sterile Manager, he would manage staff and resources to maximize productivity, cost effectiveness, and ensure high quality patient care. He has a track record of implementing policies and procedures to maintain compliance with regulatory standards.
Nancy Hudson has over 20 years of experience in office operations, human resources, and healthcare administration. She most recently served as the Office Coordinator for Beebe Internal Medicine, where she managed the daily operations of a busy medical practice. Prior to that, she spent 10 years in various roles, including Practice Administrator and Practice Manager, at St. Helena Hospital, where she oversaw multiple physician practices, coordinated the opening of new offices, and improved operational processes. She also has experience as an Office Operations Manager at Deloitte, where she directed office administration and infrastructure.
Kimberly K Kenney is seeking a position in the medical field where she can utilize over 20 years of experience as an office manager and medical assistant. She currently works as the office manager and lead medical assistant for Dr. John and Dr. Justine Gelinas' OB-GYN practice, where she oversees all clinical and office operations. Her experience also includes roles as a medical assistant for other medical practices. She has extensive skills in clinical procedures, office management, billing, and training/supervising staff. She aims to apply her strong organizational, problem-solving, and communication skills to benefit a successful medical practice.
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.
The document is a resume for Cristina Schrimp applying for a Nuclear Medicine Supervisor position. She has over 15 years of experience in various medical roles including as a Nuclear Medicine and PET/CT Technologist, MRI Coordinator, and Healthcare Screener. Her skills include workflow optimization, attention to detail, problem solving, teamwork, customer service, and leadership. She is certified in nuclear medicine and has operated various medical imaging equipment while adhering to safety procedures. She is currently pursuing an MBA and has a background in healthcare management.
Nathan Malone is seeking a challenging and fast-paced opportunity to use his skills and experience in clinic management, EMR training, and operational communications. He has over 10 years of experience in these areas, currently working as a Practice Administrator for the Heart Institute of Colorado. Prior to that, he held various roles at INTEGRIS CARDIOVASCULAR PHYSICIANS including Epic Credentialed Trainer, HIM Manager, Communication & Training Manager, and Clinic Manager. He is pursuing an MBA in Health Care Administration from Southern Nazarene University.
Marie-Noëlle Debelle's curriculum vitae outlines her educational background including a Master's in Biology from the Catholic University of Louvain and over 30 years of experience in the pharmaceutical industry, primarily at GlaxoSmithKline Biologicals where she has held several senior management roles focused on quality, risk management, and regulatory affairs.
Jesse Mitsch has over 20 years of experience in clinical operations management, medical supply logistics, and surgical assistance. He has a background in the military as a clinical operations manager, where he oversaw medical department operations and a staff of 20. He currently works as a surgical technician assisting with minimally invasive spine surgeries. Mitsch has extensive leadership experience managing medical teams and ensuring quality patient care. He also has expertise in medical equipment, inventory management, and vendor relationships.
This document describes the development of modules to improve productivity in endoscopy units. It outlines several new and revised modules that were created, which focus on areas like referral management, patient experience, and pre-assessment. The modules were tested by teams at various hospital sites. Measures were also developed to track performance across domains like quality, staff morale, timeliness and cost. Feedback from medical professionals highlighted how the modules helped standardize processes, reduce delays and improve communication to enhance the patient experience. The overall goal was to create a comprehensive guide for optimizing endoscopy unit operations.
This document summarizes the professional experience of Filbert John Aquino as a healthcare administrator and surgical assistant. He has over 20 years of experience in roles such as administrator of the Warm Springs Surgery Center, surgical first assistant at St. Rose Delima hospital, and manager of the Las Vegas Surgery Center. His experiences demonstrate skills in management, operations, quality improvement, and assisting physicians with surgeries.
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.
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.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
Darcy Szecsy has over 15 years of experience in scientific research roles. From 2005-2015, she worked at Bastion Technologies as a Scientist in their Neurosciences Laboratory, where she reviewed scientific papers, developed testing procedures and schedules, and tracked protocol development. She previously worked as an Integration Coordinator from 2006-2012, where she planned and coordinated multi-disciplinary research studies from start to finish. Szecsy has also held roles as a Laboratory Coordinator processing and transporting biological samples, and as an Experiment Support Scientist supporting hardware development for experiments in space. She has a Bachelor's degree in Marine Biology from Texas A&M University.
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.
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.
Lori Hall has over 32 years of experience leading complex global clinical research projects across various therapeutic areas such as respiratory, neurology, and gastroenterology. She has expertise in project management, budgeting, vendor management, and ensuring compliance. Hall's background includes roles such as Operational Scientific Lead, Study Manager, and Data Scientist. She is skilled in training teams, developing tools and processes to improve efficiency, and communicating with cross-functional groups and executive management.
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.
This document provides a summary of Rajeev Shrivastava's career experience in clinical research. He is currently the Associate Director of Clinical Research at Eli Lilly and Company in India, overseeing clinical operations. Previously he held roles of increasing responsibility at Eli Lilly, Novartis Pharmaceuticals, and Reliance Clinical Research Services managing various clinical trials across therapeutic areas like oncology, endocrinology, and psychiatry. His experience includes project management, site selection, regulatory submissions, study start up, monitoring, and close out.
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.
Francine Kloszewski has over 28 years of experience in the pharmaceutical industry, with expertise in managing clinical trials from Phase 1 through Phase 3. She has a strong track record of meeting project timelines and deliverables. Her experience includes managing studies across various therapeutic areas for companies such as Worldwide Clinical Trials, inVentiv Health Clinical, RPS, Adolor Corporation, and Sanofi-Aventis.
This document provides a summary of Sue Wass's work experience and skills. She has over 26 years of experience working in the NHS, including roles implementing various clinical systems like Lorenzo and iPM. Her experience includes business process mapping, system configuration, testing, training staff, and supporting go-lives. Most recently she was a business change lead at Sheffield Teaching Hospitals, where she led workstreams and helped deploy multiple Lorenzo releases. She has extensive experience implementing Lorenzo at various trusts since 2005.
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.
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.
Lisa Forbes has over 30 years of experience in clinical research coordination and administration. She has worked extensively on clinical trials and research studies in oncology, hematology, and HIV medicine. Her roles have included coordinating trials, maintaining regulatory compliance, collecting and managing clinical data, and assisting principal investigators. She is proficient in Microsoft Word and has strong communication, organizational, and public relations skills.
Lesley Carolyn Bloom has over 24 years of experience as a manager and supervisor in clinical pathology laboratories. She holds a BSc in Physiology and Medical Laboratory Sciences and is a registered biomedical scientist. Her career history includes roles managing hematology, semi-automation, and flow cytometry departments for various private and public clinical laboratories in the UK.
This curriculum vitae summarizes Marie-Noëlle Debelle's education and 30 year career in the pharmaceutical industry. She holds a Master's degree in Biology from the Catholic University of Louvain and has worked at GlaxoSmithKline since 1987, holding various quality assurance and risk management roles ensuring regulatory compliance. Her experience includes training, developing standard operating procedures, and preparing for and managing audits and inspections.
Amy Opheim has over 6 years of experience in pharmaceutical sales and clinical trials coordination. She currently works as a Customer Service Associate at Publicis Touchpoint Solutions, where she focuses on AstraZeneca's top drugs and increases sales through sampling and cost/coverage messaging. Previously, she held multiple roles at the Nanoscience and Nanotechnology Institute at the University of Iowa, including laboratory technician and research assistant. She has strong skills in sales, business development, clinical trials operations, and laboratory operations.
Sandra Frazilus has over 10 years of experience in clinical data management. She received an MBA in operations management and a BSBA in project management. Currently, she is a senior clinical data manager at I3 Statprobe, where she oversees data management projects and supervises staff. Previously, she held data management roles at Pfizer and Bayer Biological/Talecris Biotherapeutics. Her experience includes phases I-IV clinical trials across several therapeutic areas.
1. NANCY MACDONALD
Rose Cottage, 5 East Road, Isleham, Cambridgeshire, CB7 5SN
Email: Nancy-macdonald1@hotmail.com Mobile: 07950 545542
I have a highly committed attitude to professionalism and quality with 11 years’ hands-on
experience in all aspects of clinical trial administration. I am well versed in liaising with
healthcare professionals. I have profound knowledge in handling and collating duties to
manage clinical trial documentation.
CORE COMPETENCIES:-
ICH-GCP MS Office CTMS and Sharepoint
Excellent
organisational
and
interpersonal
skills
Mentoring skills Managing conflicting
deadlines
SELECTED ACHIEVEMENTS:-
Instrumental in taking studies through successful client audits with no significant
findings of the TMF. I also played a key role in the preparation and participation of a
successful MHRA inspection.
Lead CTA on global projects resulting in a huge amount of co-ordination and liaison
with other team members from start to end of the project.
PROFESSIONAL EMPLOYMENT
Mar 2008 - Present Senior Clinical Trials Assistant, SynteractHCR Ltd (SHCR), Ely
Interface with Client representatives and SHCR study team to ensure timely initiation
and completion of clinical trials. Assisting with all aspects of trial management in
accordance with the ICH-GCP, applicable local regulations and Standard Operating
Procedures.
Serving as a mentor to junior CTAs by providing guidance, training and direction in
project-related tasks and departmental processes.
Creating Trial Master Files and Investigator Site Files and support in maintaining these
for the duration of the study.
Maintaining and updating project-related data in an existing database (CTMS) which
involves liaising with internal team members to gather information and resolve queries.
This includes preparation of status reports for the study team and client.
Assisting in the preparation, receipt, collection, tracking and review of essential
documents to confirm completeness.
Arranging translations of study documents for global studies.
Assisting in the planning, organisation and execution of project-specific meetings.
Page 1 of 4
2. Preparing and contributing to study related correspondence, including meeting
minutes, tracking spreadsheets and presentations.
Responsible for the shipment and tracking of trial materials.
Contributing to preparation, support and follow-up of study specific audits.
Developing/adapting documents according to study related requirements.
Accompanying CRAs on site visits.
Apr 2006 – Mar 2008 Clinical Trials Administrator, Astex Therapeutics Ltd,
Cambridge
Filing and tracking study related documentation in TMFs and eTMFs using Sharepoint.
Management of clinical document storage facilities (electronic, fire safe and off-site
archiving). Nominated archivist for clinical trial documentation.
Assisting in submission of clinical trial documentation to the regulatory authorities and
ethics committees.
Arranging and taking minutes at Product Team meetings.
SOP controller for all company SOPs related to Clinical Trials. Assist in compiling and
reviewing specific SOPs.
Control of quality documentation relating to CRO, Site and internal audits.
Supportive administrative role for the Clinical Operations Team.
Nov 2004 – Apr 2006 Clinical Trials Administrator, Cambridge Clinical Research
(CCR), Bottisham, Cambridge
Responsible for the preparation of start up documentation relating to REC and Trust
R&D submissions in line with the European Directive and ICH-GCP.
Updating study tracking software for study status reporting.
Support in co-ordination of study related meetings – Investigator, site selection and
initiation; co-ordination with the site and sponsor company.
Supporting the Business Development Manager in the co-ordination of outgoing and
incoming feasibility to meet required timelines.
Responsible for study filing and archiving.
Apr 2002 – Nov 2004 Office Administrator, Cambridge Clinical Research
Responsible for general office & clinical trial administration.
Generation of clinical trial document templates.
Managing a system for tracking clinical trial documentation.
Filing business and clinical trial documentation.
Arranging & organising internal and external meetings.
Management of diaries & schedules.
Booking flights/transport & hotel accommodation for training courses.
Personnel issues such as recruitment, training and arranging honorary contracts.
Facilities management.
Jan 2002 – Mar 2002 HR Secretary/Administrator, NHS Executive, Cambridge
(This was a 3-month temporary assignment)
Preparation of adverts and interview paperwork.
Collating CVs, job descriptions and personal specifications.
Management of personnel files.
Answering queries, organising meetings/conferences, diary management and
supporting the Workforce Development team with any other HR administration.
Nov 2001 – Dec 2001 Various short term temporary administrative assignments
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3. Oct – Nov 2001 Administrative Assistant, BioRobotics Ltd, Cambridge
General administrative and secretarial duties for the Field Applications and Laboratory
Managers.
Arranging travel and accommodation for the company personnel and clients.
Organising monthly lab courses held within the company. Co-ordinating all course
material and collating customer questionnaires.
Management of documentation both paper and electronic. Filing, indexing and
cataloguing.
Covering reception to include tracking and checking invoices, purchase orders and
deliveries.
Apr – Oct 2001 Tour Administrator, ETS Travel, Stapleford, Cambridge
Tour operation of school & educational tours.
Liaising with suppliers and support departments with respect to transport, visits and
accommodation.
Raising and tracking tour invoices and chasing and processing payments.
May 1998 – Apr 2001 Continuing Professional Development Administrator,
Addenbrookes NHS Trust, Cambridge.
Arranging training courses and conferences for GPs, including managing the training
budgets.
Processing meeting requests and payments for the Postgraduate Education
Allowance System for GPs.
Maintenance of Doctors' Retainer Scheme database.
General secretarial support to six Directors.
Arranging and taking minutes at meetings.
Jan 1997 - May 1998 Administrative Officer, MRC Dunn Nutrition, Cambridge
An administrative role on the National Diet and Nutrition Survey for Young People.
Assisting with the recruitment of phlebotomists.
Regular liaison with the Office for National Statistics.
Organising briefings.
Data entry of confidential client information.
Jun 1995 – Aug 1988 Various Travel Consultancy positions
FURTHER EDUCATION AND PROFESSIONAL QUALIFICATIONS
Jan 2015 SHCR – GCP Update & UK Legislation Refresher
Aug 2014 SHCR – EU Clinical Trial Regulation
Feb 2014 SHCR – BioClinica OnPoint CTMS
Jun 2010 ECCRT, Brussels – CTA Workshop
Mar 2010 SHCR – Ethics and R&D Workshop
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4. Mar 2009 SHCR – Clinical Trial Directive & UK Legislation; European Regulatory
Requirements (updates every 2 years thereafter)
Jan 2009 SHCR – ICH – GCP Training (updates every 2 years thereafter)
Nov 2008 SHCR - Introduction to Pharmacovigilance
Sep 2008 SHCR - International CTA workshop
Jun 2007 Astex Therapeutics – Archiving Clinical Trial Documentation
Oct 2004 Adamas Consulting – Clinical Trials Auditing
Jul 2003 ICR – Clinical Trial Administration ‘Beyond the Basics’
Feb 2003 Adamas Consulting – GCP for Administrators Course
2000 Cambridge Regional College – NVQ Level 3 in Administration.
1997 Cottenham Village College, Cambridge – RSA Grade 3 in Word
Processing, RSA Grade 1 in Computer Literacy
EDUCATION
1983 - 1985 Colchester Institute, Colchester – A-Level French
1978 - 1983 St. Mary’s School, Colchester – O-Level French, Maths, History, Music,
Geography, English Literature and English Language
INTERESTS Theatre, travel, interior design, gardening, keeping fit, baking and
entertaining
REFERENCES By request
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