Regulatory Affairs Manager
Hyde Park Campus
About the Unit
The mission of the Clinical Research Support Office (CRSO) is to promote and facilitate the conduct of clinical research in the Department of Medicine. The Department of Medicine has a long tradition of conducting original and rigorous biomedical and clinical research of fundamental significance. The CRSO assists in the expansion of this remarkable research program by providing centralized support services for our faculty.
The Regulatory Affairs Manager functions as an essential members of our dynamic clinical research team by managing regulatory functions for studies conducted in the Department of Medicine. These clinical research studies may involve various areas of medicine and modalities of treatment. Research projects include investigator authored studies, as well as industry sponsored research. Regulatory Affairs Managers handle all regulatory functions for a large portfolio of studies. This includes Institutional Review Board (IRB) approval, all specialty subcommittee reviews, and FDA IND and IDE approvals. Regulatory Managers serve as liaisons between principle investigator (PI), co-investigators, sponsoring agents, regulatory agencies, and other members of the research team. Regulatory Managers lead PI's and study teams in meeting internal and external regulatory compliance requirements, and serve a vital role during all study audits.
- Partner with PI study team to maximize clinical research efficiency and progress
- Consult with PI team regarding strategic study planning
- Participate in protocol document writing
- Facilitate study initiation through meticulous and timely preparation of IRB, sub-committee and FDA submissions
- Prepare and maintain all materials related to IRB and FDA approvals throughout the life of the study
- Ensure successful monitoring and auditing of studies including FDA, sponsor and/or internal study audits
- Present research portfolio progress during research team meetings
- Provide guidance to faculty regarding compliance, funding and research support resources
- Maintain a high level of self-education to include review of articles related to clinical research; attend multi-disciplinary conferences; attend workshops specific to work area.
- Assist in the orientation and training of new and current Clinical Research Support Office staff and/or staff in the various sections of the Department of Medicine.
- Outstanding project management.
- Excellent verbal and written communication skills.
- Ability to manage stressful situations.
- Analytical thinking and problem-solving.
- Attention to detail.
- Strong organizational skills.
- Strong Interpersonal skills.
- Work independently with a high degree of initiative.
- Work as part of a team.
- Ability to maintain confidentiality.
- Proficiency with Microsoft Word and Excel required.
- Proficiency with Adobe Acrobat preferred.
Education and Experience:
- Bachelor's degree required.
- 1-2 years of project management experience required.
- Regulatory compliance experience preferred.
- Clinical research and/or data management experience preferred.
- Experience at a large academic or medical institution preferred.
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Background Check Required?
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