Director Human Subjects Protections

Job Duties:

• 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

• 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

• 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

Special Instructions To Application:

Minimum Education/Experience:

• Post-baccalaureate education in a relevant scientific or health care discipline
• Thorough knowledge of federal regulatory requirements regarding research involving humans, including regulations from FDA, DHHS, NIH, OCR.
• Thorough knowledge of the research setting in a medical and health care environment.
• Certification or certification-eligible as a Certified IRB Professional (CIP)
• Strong communication skills, both verbal and written
• Working knowledge of federal requirements for research compliance
• Familiar with Behavioral and/or Social Science research methods and procedures

Full time or Part time: Full Time

Position Location (city): Greenville

Position Number: 000442

Organizational Unit Overview: