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)

About Moffitt Cancer Center

Moffitt Cancer Center is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 53 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research and robust training and education. Moffitt has been nationally ranked by U.S. News & World Report. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet®, its highest distinction. With more than 7,000 team members, Moffitt has an economic impact in the state of $2.4 billion.

Connections working at Moffitt Cancer Center