The University of North Carolina at Chapel Hill
Location
Chapel Hill, NC | United States
Job description
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 )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.
About The University of North Carolina at Chapel Hill
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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