Research Compliance Specialist

Description

Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.

Summary:

Participates in the development, implementation, and monitoring of institutional procedures to ensure compliance with federal, state, and local regulations governing research activities. Promotes ethical conduct, regulatory integrity, and operational excellence in human subjects and other regulated research programs.

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

Education Requirements:
* Bachelor's degree in a relevant field required (e.g., life sciences, research administration, public health), Master's degree preferred.
Licensure/Certification Requirements:
* Minimum of 5 years in research compliance, IRB administration or related research oversight role.
Professional Experience Requirements:
* CHRC, CIP, or equivalent preferred.
Knowledge/Skills/and Abilities Requirements:
* 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

Legal Employer: NCHEALTH

Entity: Shared Services

Organization Unit: Research Compliance

Work Type: Full Time

Standard Hours Per Week: 40.00

Salary Range:$33.37 - $47.97 per hour (Hiring Range)

Pay offers are determined by experience and internal equity

Work Assignment Type: Remote

Work Schedule: Day Job

Location of Job: US:NC:Chapel Hill

Exempt From Overtime: Exempt: Yes

This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care; except that, if you are currently a UNCHCS State employee already working in a designated shared services department, you may remain a UNCHCS State employee if selected for this job.

Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email applicant.accommodations@unchealth.unc.edu if you need a reasonable accommodation to search and/or to apply for a career opportunity.