Facilitates the ethical conduct of clinical research and ensuring that it is conducted in a manner compliant with all federal, state and local regulations, as well as institutional policies.
1. Provides guidance to investigators and research staff to facilitate the ethical conduct of research by assisting with questions regarding submission preparation and requirements.
2. Triages all types of submissions including new studies, amendments, renewals, and incidents (i.e., unanticipated problems)
3. Conducts regulatory review of research protocol submissions for compliance with applicable federal regulations and federal policies.
4. Substantively interprets applicable federal and state regulations when analyzing each submission to conduct an in-depth pre-review.
5. Participates in research compliance board meetings (IRB, IBC); prepares agenda, records minutes, documents vote, etc.
6. Provides written reports summarizing findings for review/approval by committee chair(s).
7. Determines appropriate risk categories, exempt and expedited categories, and other regulatory determinations (e.g. subpart determinations, IDE/IND determinations, etc.) for studies per all applicable regulations (OHRP, OLAW, NIH, FDA. etc.) before forwarding to committee/chair.
8. Provides feedback to investigators and research coordinators to guide them in making necessary modifications to submissions in order to meet regulations and obtain approval before and after the compliance committee meeting
9. Assists in the development and maintenance of compliance programs, including but not limited to departmental policies and procedures, educational/training materials, associated forms, and is responsible for ensuring changes in regulatory and institutional requirements are integrated in draft policies.
10. Tracks and monitors submissions by maintaining database and providing regular reports to the Director and Chair(s).
11. Participates in compliance audits, post approval monitoring, accreditation applications, site visits an reports
12. Contributes to website development, the development of quality assurance initiatives, as well as other special projects as needed.
13. Demonstrates desire and initiative to increase knowledge and skills in research compliance by participating in internal/external educational events and research and/or compliance meeting.
14. Maintains office files in accordance with regulatory guidelines (OHRP, FDA, etc.).
1. High School Diploma with 3 to 5 years of experience – OR Assoc. Degree /2 years of college with 2 to 4 years exp. – OR Bachelor’s Degree with 1 to 3 years of experience.
2. Must possess strong written and verbal communication skills, and be detailed oriented. Must possess the ability to communicate with all levels of faculty and staff within the institution in an accurate, helpful, and customer service oriented manner.
3. Candidate must be able to make independent decisions and function independently with minimal supervision. Candidate should be able to function with a high level of discretion and confidentiality.
4. Must possess current knowledge of federal, state and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP, and FDA.
5. Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
6. Maintenance of membership in a related professional organization and conference attendance is expected, such as PRIM&R.