Working under general supervision from the Principal Investigator, or manager, and following established policies and procedures, will provide assistance on clinical research studies, implement and coordinate research and administrative procedures for the successful management of clinical trials. Will be responsible for the following activities: coordination of clinical trials, including oversight and start-up of clinical trial activities, interaction with sponsors and administrative departments within BWH and investigator team for smooth start-up and conduct of clinical trials, recruiting potential subjects and evaluating patients for studies, conducting study visits as per protocol, performing clinical tests required by the protocol such as phlebotomy, EKG’s, etc.; retaining participants in studies, collecting and organizing participant data; scheduling participant for study visit; maintaining and updating data generated by the study, and performing diverse administrative duties requiring sound judgement and a high level of knowledge of study-specific protocols.
1. Provide assistance on clinical research studies as per studies guidelines and protocols. 2. Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process. 3. Develop informed consent documents, source documents, and other documents as applicable. 4. Recruit and evaluate potential study participants. Adhere to protocol requirements for all study conduct. May be required to perform clinical tests such as phlebotomy, EKG’s, vital signs, coordinate visits and specimen collection. 5. Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education, procedural instruction, and follow-up. Serve as a liaison between study participant and research team. 6. Responsible for collecting data and maintaining participant information database for study. May be required to input data, do minimum analysis and run various reports. 7. Support the safety of clinical research participants. 8. Understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions. 9. Responsible for mailing various study information or packets to study participants. 10. Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated. 11. Responsible for training and orienting new staff. May serve as a team leader or in a supervisory capacity in a smaller area. 12. Interact with study monitors, scheduling monitoring visits as indicated, and providing timely responses to study queries. 13. Maintain study inventory and order study supplies when necessary. 14. Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols. 15. Communicate with participant’s clinical care providers as needed and document research visits within electronic health record system, in compliance with institutional policies. 16. Contribute to research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members, and contributing to research meetings. 17. All other duties, as assigned.
Skills/Abilities/Competencies Required: Careful attention to detail. Good oral and written communication skills. Excellent organization skills and ability to prioritize a variety of tasks. Ability to work independently. Excellent interpersonal skills are required for working with the study participants, participants’ clinical care team, and research team members. Analytical skills and the ability to resolve technical or research problems. Knowledge of clinical research protocols. Ability to demonstrate respect for participants’ rights and individual needs.
SUPERVISORY RESPONSIBILITIES: Responsible for training and orienting new staff. May serve as a team leader or in a supervisory capacity in a smaller area.
About Brigham & Women's Hospital
Brigham Health is a global leader, devoted to maintaining and restoring health for people everywhere. Brigham Health is composed of Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, and Brigham and Women’s Physicians Organization.
Boston’s Brigham and Women’s Hospital (BWH) is an international leader in virtually every area of medicine and has been the site of pioneering breakthroughs that have improved lives around the world. A major teaching hospital of Harvard Medical School, BWH has a legacy of excellence that continues to grow year after year. BWH includes 150 outpatient practices with over 1,200 physicians. We serve patients from New England, throughout the United States, and from 120 countries around the world.
BWH is an internationally-known referral center for the most complex cases in nearly all areas of medicine. In fact, U.S. News and World Report has consistently ranked us a top hospital and among the best in specialty areas including cancer, cardiology and heart surgery, gynecology, neurology and neurosurgery, orthopedics, and rheumatology.