IRB PROGRAM MANAGER (Job Code 1949)

Apply online at: http://www1.wfubmc.edu/wfuhs_hr/

FUNCTION OF JOB

Under administrative review, provide planning, direction, and oversight to the
research ethics and regulatory processes related to the protection of human
research participants at non-WFUHS sites.

CHARACTERISTIC WORK

1. Manage external sites in which WFUHS IRB is the IRB of record to include
the education, training, and monitoring of human research occurring at the
sites.

2. Conduct audits of external sites on a regular basis to ensure investigator
practice conforms to applicable regulations, policies, ethical principles, and IRB
approved protocols. Draft detailed reports outlining audit findings,
recommendations, and corrective actions.

3. Manage the IRB Authorization Agreement process.

4. Serve as the primary point of contact with the external research
community. Utilize expertise in regulatory matters and IRB policies. Assist
investigators and study team members in the preparation of IRB applications,
contracts, and informed consent forms.

5. Facilitate IRB operations on behalf of WFUHS. Implement and communicate
policies and procedures, federal, state, and local regulations relating to human
subjects involved in medical or behavioral research.

6. Provide guidance regarding submission of clinical protocols for IRB review.
Advise researchers regarding policies and procedures, assist in preparing
written standard operating procedures, follow-up on IRB recommendations to
verify compliance, and ensure no human research is performed beyond IRB
authorized time periods.

7. Review and approve protocol amendments.

8. Manage review of protocol submissions for completeness of materials, and
adherence to institutional policies and procedures and federal regulations.

9. Maintain complex records of protocols and actions taken through the course
of their existence to be complete and available for audits by federal regulatory
agencies.

10. Establish and maintain protocol records and database for human subjects
research. Create statistical and administrative reports related to IRB activity
and human subject research.

11. Present information to review committees and answer any questions of
concern.

12. Assist in overseeing budget and making recommendations for financial
decisions.

13. Perform other related duties incidental to work described herein.

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