The mission of the Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Women's Hospital, by building services helpful to clinical investigators and facilitating the success of individual investigators. CCI is organized into 6 programs, each led by a BWH faculty member.
Working very independently and under very general supervision from a manager or Principal Investigator, provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, screening and scheduling potential participants for clinical trials, developing and implementing patient recruitment strategies, performing applicable clinical tests such as phlebotomy, ECGs, etc, maintaining and updating data generated by the study, recommending changes to protocols, and overseeing the work of more entry level staff.
Principal Duties and Responsibilities:
1.Coordinates the implementation, both internally and externally, of sponsored clinical research studies.
2.Initiates and maintains recruitment contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation. May be required to perform clinical tests such as phlebotomy, ECGs, etc.
3.Working in concert with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies.
4.Interacts with patients/subjects with regard to the study, including patient education, procedural instruction, and follow-up. Serves as a liaison between patient and physician, and as a resource for participants and their families.
5.Responsible for collection data and maintaining patient information databases for the study. Develops, organizes, and/or maintains the study forms. Responsible for data validation and quality control, data entry into CRFs, if applicable. May be required to input data, and do minimal analysis and run various reports.
6.In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.
7.Responsible for mailing various study information or packets to study participants.
8.Answers phone calls and inquire regarding the study protocol. Refers participants when appropriate to principal and co-investigators.
9.Communicates regularly with the PI(s) about all aspects of the research trial.
10. Ensure that knowledge about regulatory requirements are current by reading and attending local seminars related to policy and regulatory issues (FDA, NIH, IRB, etc.)
11. Meet regularly with Medical Director, Manager, and CCI Administration.
12. Participate in ongoing training and educational activities with CCI. Responsible for providing support for CCI program development.
13. Monitors, maintains, sets up any study equipment.
14. Maintains inventory and orders supplies when necessary.
15. All other duties, as assigned.
1.BS OR BA
2.1 -3 years of work experience in clinical research, preferably actively coordinating research trials. Experience with Good Clinical Practice, CRFs, laboratory processes, safety practices, specimen shipping/handling, and study conduct.
3.Sound independent judgment and competence in research methodologies.
Skills/ Abilities/ Competencies Required:
1.Ability to work independently.
2.Excellent interpersonal skills are required for working with the study participants.
3.Good oral and written communication skills.
4.Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
5.Knowledge of clinical research protocols.
6.High degree of computer literacy.
7.Excellent organizational skills and ability to prioritize a variety of tasks.
8.Careful attention to detail.
9.Ability to demonstrate professionalism and respect for subject's rights and individual needs.
10. Knowledge of data management programs.
11. Coordinator certification preferred