Regulatory Associate Lead

3 weeks ago


Chapel Hill, North Carolina, United States InsideHigherEd Full time
Job Title: Regulatory Associate Lead

We are seeking a highly skilled Regulatory Associate Lead to join our team at the University of North Carolina at Chapel Hill. As a key member of our Clinical Trials Office, you will play a critical role in ensuring the conduct of oncology clinical trials is compliant with federal regulations, Good Clinical Practice, and local and institutional policies.

Key Responsibilities:
  • Assist in the activation of new oncology clinical trials, including preparing and submitting regulatory documents to the IRB and ancillary committees.
  • Prepare and submit regulatory applications, forms, and documents required to conduct clinical research at UNC LCCC.
  • Ensure regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB.
  • Assist with the maintenance of the regulatory binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence).
Requirements:
  • Bachelor's degree in a discipline related to the field assigned and one year of related training or experience.
  • Demonstrated experience in clinical research, including advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812, and ICH GCP Guidelines.
  • Strong decision-making skills and the ability to problem solve and troubleshoot issues.
  • High level of accuracy and attention to detail.
Preferred Qualifications:
  • Experience preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions.
  • Experience preparing submissions to ancillary committees, such as the Protocol Review Committee, Institutional Biosafety Committee, Investigational Drug Services, Radiation Safety Subcommittee.

We offer a comprehensive benefits package, paid leave, and a variety of health, life, and retirement plans. If you are a motivated and detail-oriented individual with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.


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