Regulatory Affairs Coordinator II

Position Type: Admin/Professional

Department: Research & Sponsored Programs

Full or Part Time: Full Time

Pay Grade: MN8

Summary:

Supports the administrative components of the Institutional Animal Institutional Review Board (IRB ), Institutional Biosafety Committee (IBC ), and Radiation and Laser Safety Committee (RLSC ) to assure compliance with applicable institutional policies/external regulatory/policy requirements. Participate in human subject’s research policy development/implementation/analysis. Prepares human subject research reports. Provides administrative support to the IRB, IBC, and RLSC . Serves as a contact point for IACUC, IRB, IBC, and RLSC inquiries from outside entities including Redizone clients and partner universities.

Principal Functional Responsibilities:

Committee Administration and Daily Operations: Manage daily operations of NEOMED’s IRB, IBC, and RLSC . Maintain accurate digital records of all compliance committee activities (e.g., meeting minutes, applications, correspondence). Manage databases tracking IRB and IBC activities. Screen incoming applications (IRB, biosafety, radiation/laser) for completeness and regulatory compliance.

Regulatory and Protocol Communications: Draft regulatory documents: approval, amendment, and denial memos. Act as liaison between committees and researchers to communicate decisions and required changes. Advise reviewers on regulatory requirements, policies, and historical practices.

Researcher Support and Education: Provide guidance to research personnel (faculty, staff, students) on protocol development and application preparation. Meet with investigators to review submissions and offer improvement suggestions. Serve as a voting IRB member.

Project Review and Determinations: Review PI requests for project classification (research, quality improvement, or program evaluation). Issue “not research” certificates for projects not meeting federal definitions of human subjects research. Forward applicable projects to the full committee for additional review.

Regulatory Reporting and Compliance: Prepare and file annual reports to NIH OBA, OHRP, and ORI . Maintain NEOMED’s Federal Wide Assurance (FWA ) and committee registrations. Prepare and distribute quarterly IRB activity reports.

Inter-Institutional Agreements: Negotiate and draft IRB Authorization Agreements with collaborating institutions. Determines when NEOMED’s FWA should extend to external institutions or investigators.

Other Duties: Perform other duties as assigned.

Qualifications:

• Bachelor’s degree or equivalent in education and experience

• 5 years’ experience in compliance administration in research or health care setting

• Certification from the National Council of Research Administrations (CRA ) or other professional society certification of research administration knowledge required or eligibility of certification within two years required

Requires the ability to analyze and understand issues with the respective entities and represent NEOMED’s best interests with all stakeholders. Must also be able to articulate and execute plans on behalf of NEOMED, assuring regulatory compliance and aligning with its local/regional stakeholder goals.

Preferred Qualifications:

Physical Requirements:

Must be able to utilize a phone, computer and other office equipment.

Department Specific Information:

Research & Sponsored Programs_Specific_Information

To apply, visit https://apptrkr.com/6320013

NEOMED is committed to providing equal employment opportunities to qualified applicants without discrimination on the basis of age, color, disability, gender identity or expression, genetic information, national origin, race, religion, sex, sexual orientation, transgender status, status as a parent during pregnancy and immediately after the birth of a child, status as a parent of a young child, status as a foster parent, veteran status or any other category protected by applicable state or federal law. As an Equal Opportunity Employer, NEOMED also affirms its commitment to nondiscrimination in its employment policies and practices. In compliance with Title IX (20 U.S.C Sec. 1681 et seq.), NEOMED prohibits sex discrimination, including sexual harassment.