Employment Type: Permanent Staff (EHRA NF)

　　Vacancy ID: NF0007742

　　Position Summary/Description:

　　The purpose of Regulatory Associate is to facilitate the conduct of oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for:

　　Preparing, submitting, and processing regulatory applications, forms and documents required to conduct clinical research at UNC LCCC to the to the Institutional Review Board ( IRB ) and ancillary committees, including the Protocol Review Committee ( PRC ), Data Safety Monitoring Committee ( DSMC ), Institutional Biosafety Committee ( IBC ), Compliance Committee, and Radiation Safety Subcommittee ( RSS )

　　Preparing informed consent forms, HIPAA documents, and participant materials

　　Ensuring regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB , contributing to development of CAPAs and root causes analyses for non-compliance events, and tracking and recording pending regulatory and compliance actions through completion on study team trackers and in clinical trial management system

　　Providing updates (oral and/or written) on status of pending regulatory actions and compliance at study team and compliance meetings

　　Preparing for monitoring and audit visits and addressing regulatory findings within required deadlines

　　Assisting 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).

　　The Regulatory Associate also includes involvement in process improvements and training such as writing and reviewing standard operating procedures and work instructions, mentoring new Regulatory team members, participating on Clinical Trials Office ( CTO ) committees, and assisting in training Regulatory team members.

　　These responsibilities relate to the UNC / LCCC clinical research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

　　Education and Experience:

　　At least 1 year of experience preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, 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 preferred.

　　AA/EEO Statement:

　　The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.