East Carolina University's mission is to be a national model for student success, public service and regional transformation. Located in eastern North Carolina, ECU:
- Uses innovative learning strategies and delivery methods to maximize access;
- Prepares students with the knowledge, skills and values to succeed in a global, multicultural society;
- Develops tomorrow's leaders to serve and inspire positive change;
- Discovers new knowledge and innovations to support a thriving future for eastern North Carolina and beyond;
- Transforms health care, promotes wellness, and reduces health disparities; and
- Improves quality of life through cultural enrichment, academics, the arts, and athletics.
We accomplish our mission through education, research, creative activities, and service while being good stewards of the resources entrusted to us.
ECU is searching for a Director of Human Subjects Protections.
The Director of Human Subjects Protections is expected to function as a comprehensive IRB professional with an in-depth understanding of the federal research regulations and the ability to direct and manage all aspects of the IRB process. The Director will ensure the overall effective operation of the regulatory, administrative, and business processes of the University and Medical Center Institutional Review Board (UMCIRB).
The Director plays a vital role for ensuring that the UMCIRB office and committee operates in a manner consistent with the federal regulations through drafting, reviewing and revising IRB processes and procedures. This position is required to provide support to investigators, from novice to expert, in various disciplines across the university and hospital campuses in preparation of their IRB applications.
This position performs the following duties:
Administration of Human Research Program – 60%
- Provide human subject research guidance and education to UMCIRB staff and committee members, and faculty/staff/student investigators (individually or departmental)
- Assist local investigators conducting human research in the development of their proposals to be submitted for IRB approval or External IRB confirmation
- Assist local investigators and IRB members/chairs with non-human research activities such as Emergency Use and Expanded Access projects, and Humanitarian Use Devices.
- Interact and communicate with local institutional and regulatory officials regarding human research
- Recruit appropriate and engaged individuals to become UMCIRB members
- Manage, train and support UMCIRB members on two boards (Biomedical and Behavioral/Social Sciences)
- Oversee HIPAA Privacy Board and HIPAA Research activities
- Research, propose and develop necessary and appropriate policy/procedure changes within the UMCIRB according to local, state and federal policy changes and guidance
- Compile, assess and manage UMCIRB data for institutional assessment purposes
- Consult with and query federal regulatory agents (OHRP, FDA, DOD, etc.) as needed for guidance to ensure UMCIRB's satisfaction of regulatory requirements
- Review and provide guidance to IRB Chairs/members on individual human research submissions
- Prepare UMCIRB meeting agenda and minutes
- Serve as the HHS, Office for Human Research Protections (OHRP) Human Protections Administrator (HPA) for ECU
- Update and revise Federal Wide Assurance (FWA) and UMCIRB rosters with the Office of Human Research Protections (OHRP)
- Draft and maintain ECU Individual Investigator Agreements with individual research team members
- Draft, review and execute ECU IRB Authorization Agreements with collaborating institutions and external IRBs
- Review Data Use Agreements to ensure alignment with research protocols
- Investigate human research related serious or ongoing non-compliance and unanticipated problems and report to appropriate local institutional officials, federal officials, sponsoring agencies and others as necessary
- Supervise 5 full time employees to ensure compliance with relevant regulatory/institutional policies and UMCIRB standard operating procedures
Administration of electronic IRB submission system – 20%
- Provide technical support to research investigators and others within the electronic IRB submission system
- Manage and modify workflows/smartforms and troubleshoot issues within the electronic IRB submission system
- Assist in report development from data collected within electronic IRB submission system for institutional purposes
Education and Outreach – 20%
- Develop education, training and resources for a variety of investigators and other customers as needed based on hot topics, new federal guidance or local policies/rules
- Develop local tools for determining human subject research (versus case reports, quality activities, class projects, etc.)
- Maintain and update UMCIRB website using university software
For further details related to the requirements for this position visit the ECU HR website to view the position posting in its entirety: https://ecu.peopleadmin.com/postings/81166
Please contact the Department for People Operations, Success, and Opportunity or the search committee/hiring official if you have any questions.
Kenneth Briley
Kenneth W. Briley, MSW, CIP, Search Committee Chair
Interim Director, Office of Compliance Monitoring
Office of Research
East Carolina University
209 E. 5th Street, Room 104 – Mailstop 157
Greenville, NC 27858
252.737.5558
------------------------------
Kenneth Briley
Interim Director - Office of Compliance Monitoring
East Carolina University (ECU)
------------------------------