Regulatory Associate
Not Disclosed•Full-TimeOn-site
location_on750, Weaver Dairy Road, Carol Woods, Chapel Hill, Orange County, North Carolina, 27514, United States
About the Role
The Regulatory Associate serves as a vital partner in the conduct of oncology clinical trials at UNC LCCC. This position exists to ensure rigorous regulatory compliance with federal regulations, Good Clinical Practice (GCP), and local institutional policies. By maintaining the highest standards of research quality and patient safety, the role directly safeguards institutional integrity and supports the organization's clinical research mission.
In this capacity, you will manage the end-to-end lifecycle of regulatory documentation. Your day-to-day involves preparing, submitting, and processing applications for the Institutional Review Board (IRB) and ancillary committees, including the Protocol Review Committee, Data Safety Monitoring Committee, and Biosafety Committee. You will be responsible for drafting informed consent forms and HIPAA documents, while ensuring timely reporting of unanticipated problems and non-compliance events. Additionally, you will track pending regulatory actions, assist with audit preparations, and maintain the regulatory binder within the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence).
Beyond daily operations, this role contributes to continuous improvement by writing and reviewing standard operating procedures, mentoring new team members, and participating in Clinical Trials Office committees. You will provide regular updates on compliance status during study team meetings and collaborate with the team to develop corrective action plans for any compliance issues.
Application Instructions
To apply, candidates must submit a cover letter. This document serves as a required example of your professional written communication skills and should highlight your relevant experience in clinical research and regulatory affairs.
Equal Opportunity Employer
UNC LCCC is committed to fostering a diverse and inclusive environment. We consider qualified applicants regardless of background, ensuring that our team reflects the communities we serve.
Work location
Work model: On-site
750, Weaver Dairy Road, Carol Woods, Chapel Hill, Orange County, North Carolina, 27514, United States
Chapel Hill, North Carolina
Key Responsibilities
- check_circleEnsure regulatory compliance by reporting unanticipated problems and tracking compliance actions
- check_circlePrepare for monitoring and audit visits and address regulatory findings within required deadlines
- check_circleDraft informed consent forms, HIPAA documents, and participant materials for clinical trials
- check_circleWrite and review standard operating procedures and work instructions for process improvements
- check_circleMentor new Regulatory team members and assist in training staff on compliance protocols
- check_circlePrepare, submit, and process regulatory applications and documents for IRB and ancillary committees
- check_circleMaintain regulatory binders and enter study information into electronic clinical trial management systems
Requirements
- verifiedDemonstrated experience in clinical research
- verifiedAdvanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines
- verifiedExperience preparing and submitting IRB submissions and consent forms
- verifiedStrong computer skills including Outlook, Word, Excel, and PowerPoint
- verifiedCover letter required
- verifiedAt least 1 year of experience preparing and maintaining IRB applications
- verifiedRAC, SoCRa, or ACRP certification preferred
Nice to Have
At least 1 year of experience preparing and maintaining IRB applications for therapeutic clinical research studies involving a drug or device, and/or oncology clinical research studies. Experience using an eRegulatory system (such as Florence). RAC, SoCRa, or ACRP certification.
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Frequently asked questions about Regulatory Associate at UNC Health
What does a Regulatory Associate at UNC Health do?expand_more
A Regulatory Associate at UNC Health is responsible for the following: Ensure regulatory compliance by reporting unanticipated problems and tracking compliance actions; Prepare for monitoring and audit visits and address regulatory findings within required deadlines; Draft informed consent forms, HIPAA documents, and participant materials for clinical trials; and Write and review standard operating procedures and work instructions for process improvements.
What are the requirements for this Regulatory Associate role?expand_more
UNC Health is looking for candidates who meet the following requirements: Demonstrated experience in clinical research; Advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines; Experience preparing and submitting IRB submissions and consent forms; Strong computer skills including Outlook, Word, Excel, and PowerPoint; Cover letter required; and At least 1 year of experience preparing and maintaining IRB applications.
Where is the Regulatory Associate role at UNC Health located?expand_more
Regulatory Associate at UNC Health is based in 750, Weaver Dairy Road, Carol Woods, Chapel Hill, Orange County, North Carolina, 27514, United States. This is a on-site role.
Is this Regulatory Associate job remote, hybrid, or on-site?expand_more
UNC Health has listed this Regulatory Associate role as on-site.
How much experience is required for this Regulatory Associate role?expand_more
Regulatory Associate at UNC Health typically requires 1+ years of relevant experience at the mid level level.
What skills do you need for the Regulatory Associate role at UNC Health?expand_more
Key skills for Regulatory Associate at UNC Health include 21 CFR Parts 50; 21 CFR Parts 54; 21 CFR Parts 56; 21 CFR Parts 312; 21 CFR Parts 314; 21 CFR Parts 812; Ich GCP Guidelines; and Outlook.
What category does the Regulatory Associate role belong to?expand_more
Regulatory Associate at UNC Health is part of the scientific & qa job category on Recrutus.