Regulatory Assistant Lead

Details

Posted: 12-Apr-24

Location: Chapel Hill, North Carolina

Salary: Open

Internal Number: 278073

Vacancy ID: P018927

Position Summary/Description:

The purpose of the Regulatory Assistant Lead position is to facilitate the conduct of oncology clinical trials by providing regulatory document support to ensure compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for:
* Prepares, submits, and processes in a timely and accurate manner all applicable regulatory applications (initial, modifications, continuing reviews, noncompliance/expedited reports, etc.), forms, and documents required to conduct clinical research at UNC LCCC to the following regulatory bodies for studies for which the NCI CIRB is the IRB of record:
* NCI CIRB
* Protocol Review Committee (PRC)
 Investigational Drug Services (IDS)
* Institutional Biosafety Committee (IBC)
* NCI Clinical Trials Evaluation Program (CTEP)
* Monitoring regulatory binder creation for new studies and following up with Regulatory Assistants in the I and II roles to address items
* Assisting in administrative maintenance of eRegulatory system (Florence)
* Reviewing and following up on monitoring letters and audit reports to ensure action items/findings are addressed by Regulatory Assistants
* Monitoring trends in action items/findings from monitoring letters and audit reports to help identify when process changes may be needed
* Develops, writes, and provides input on standard operating procedures, work instructions, and internal processes. 
* Assists in development, maintenance, and leading training for Regulatory staff
* Participates on CTO committees/task forces/working groups
* Attends pre-study team regulatory meetings for assigned study teams
* Participates in interviews of Regulatory Assistant applicants
* Prepares and collects essential documents for electronic regulatory binder and collecting signatures and other required information for these documents 
* Maintains regulatory binder: 
* Names regulatory documents in accordance with defined nomenclature
* Files regulatory documents in eRegulatory binder in accordance with defined filing structure
* Communicates with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required
* Tracks and records pending regulatory actions through completion on study team trackers
* Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes 
* Prepares regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines.
* Prepares, submits, and processes in a timely and accurate manner IRB applications for:
o continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record
o personnel modifications to UNC IRB
o external IND safety reports to UNC IRB 
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:

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

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Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.
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