UNC Health Care
Research Compliance Specialist
UNC Health Care, Chapel Hill, North Carolina, United States, 27517
Description
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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/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
Job Details 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.
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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/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
Job Details 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.
#J-18808-Ljbffr