H. Lee Moffitt Cancer Center

Tampa, FL

ID: 7247247 (Ref.No. hlj_53630)
Posted: May 23, 2024
Application Deadline: Open Until Filled

Job 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.


Certified IRB Professional (CIP)

Mission To create a Moffitt culture of diversity, equity, and inclusion as we strive to contribute to the prevention and cure of cancer. Vision To advance and accelerate a culture of access, equity, and inclusion. Diversity is a priority at Moffitt and is meant "to promote a culture of diversity and inclusion as we contribute to the prevention and cure of cancer." The Enterprise Equity Department focuses its efforts on eliminating those obstacles to an individual’s ability to exist within their personal comfort zone at the cancer center. Everyone is important to meeting this priority. Addressing and responding to diversity and inclusion fosters an environment where mutual respect for diverse cultures, communication styles, languages, customs, beliefs, values, traditions, experiences and other ways in which we identify ourselves, is the expectation.