UNC Health · 2 days ago
Research Compliance Specialist
United States
Full-time
Remote
Senior Level
$33.37/hr - $47.97/hr
5+ years expUNC Health is an inclusive organization with over 40,000 teammates focused on improving health and well-being. The Research Compliance Specialist participates in developing and monitoring procedures to ensure compliance with research regulations and promotes ethical conduct in research programs.
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Responsibilities
Ensures institutional research activities comply with federal, state, and local regulations (e.g., HHS, FDA, OHRP, NIH), inclusive of review of protocols, consent documents, other study documents and processes
Conducts internal audits of research projects to assess adherence to human subjects and biosafety standards
Participates in post-approval monitoring, risk assessments, and QA reviews of research programs
Participates in the implementation of research compliance policies and SOPs
Maintains awareness of evolving regulations; drafts guidance documents and recommends policy and SOP updates accordingly
Tracks corrective and preventive actions (CAPAs) and monitors their resolution
Maintains the current Conflict of Interest (COI) disclosure system for research; reviews financial disclosure forms for potential conflicts; tracks management plans and ensures investigator adherence
Supports inquiries and investigations related to research misconduct or integrity concerns
Ensures compliance with responsible conduct of research (RCR) requirements
Coordinates communications with regulatory bodies when reportable issues arise
Prepares SOPs that operationalize compliance processes across departments
Recommends process improvements to enhance research integrity and regulatory efficiency
Serves as compliance liaison across departments, providing clear interpretation of regulations and policies
Facilitates coordination with external partners or affiliates conducting research under the institution’s FWA
Develops and manages research compliance education programs for investigators, staff and students
Participates in committee meetings and represents research compliance in institutional initiatives as required
Participates in implementation and ongoing management of the research compliance Work Plan
Qualification
Required
Bachelor's degree in a relevant field required (e.g., life sciences, research administration, public health)
Minimum of 5 years in research compliance, IRB administration or related research oversight role
Strong knowledge of research ethics, compliance frameworks, and institutional policy development
Excellent communication and interpersonal skills with ability to build trust and collaborate across disciplines
Analytical and detail-oriented approach with capacity for independent judgement and discretion
Preferred
Master's degree preferred
CHRC, CIP, or equivalent preferred
Company
UNC Health
Our mission is to improve the health and well-being of North Carolinians and others whom we serve.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Chris Ellington
President UNC Health Care - Network Hospitals and EVP CFO UNC Hospitals at Chapel Hill
Jeff Lindsay
President and Chief Operating Officer
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