MGR CLIN TRIALS REG COMPLIANCE
Apply NowCompany: H. Lee Moffitt Cancer Center
Location: Tampa, FL 33647
Description:
The Manager Clinical Trials Regulatory Compliance is responsible for long- and short-term planning and oversight of regulatory activities. Interprets federal and state regulations, corporate policy, and clinical research best practices to develop and implement strategies for the earliest possible approval of regulatory submission. Advises and manages the regulatory teams, and reviews ongoing projects. Plans, schedules and directs activities and programs through regulatory staff. Negotiates with outside agencies (IRBs) as needed to resolve key regulatory issues and expedite approvals of clinical trials at Moffitt Cancer Center. Communicates regulatory submission status to programs and investigators regularly.
Education and Experience Required:
Qualified candidates will have a minimum of a Bachelor's Degree, a Master's Degree is preferred. This position requires 5+ years relevant clinical research regulatory experience. Previous supervisory or management experience strongly preferred, knowledgeable in CCSG requirements, as well as quality systems/auditing experience.
Preferred:
Certified IRB Professional (CIP)
Education and Experience Required:
Qualified candidates will have a minimum of a Bachelor's Degree, a Master's Degree is preferred. This position requires 5+ years relevant clinical research regulatory experience. Previous supervisory or management experience strongly preferred, knowledgeable in CCSG requirements, as well as quality systems/auditing experience.
Preferred:
Certified IRB Professional (CIP)