CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional)
4 Year Degree
The External Research Quality Manager will be responsible for assisting in the management of multiple clinical research protocols conducted at multiple research sites locally and nationally for the Sunshine Project. The consortium currently consists of 20 sites including Moffitt Cancer Center.
Review of Sunshine Trials during the Scientific Review Process to ensure protocol document clarity/consistency, inclusion of required adverse events reporting, data capture and monitoring processes, and requests revisions to protocol as appropriate.
Performs compliance monitoring activities including but not limited to verifying all regulatory approvals, reviews case report forms for completeness and accuracy with the medical record, determines accurate capture and reporting of participant adverse events.
Maintains OnCore Databases and oversees data entry by site.
Aides in training of external and internal staff members on various research compliance related topics.
Assists with the development and review of informed consent documents.
Reviews source documentation for verification of consent and eligibility of clinical research participants prior to trial registration.
Credentials and Qualifications:
Bachelor's degree (Master's preferred)
Four (4) years clinical research coordination experience including intervention trials. (5 years clinical research coordination experience preferred with 2 of the years monitoring clinical trials, and/or 2 years in multisite coordination).
Extensive knowledge of clinical research regulations and processes required.
Travel is required to include but is not limited to site initiation visits, monitor data at Sunshine consortium sites.
Internal Number: 34762
About Moffitt Cancer Center
Working at Moffitt Cancer Center is both a career and a mission. All our employees – from nursing to information technology - are dedicated to patient care, research and education to advance our fight against this disease. Discover what it means to be part of the Moffitt team. Join our mission to contribute to the prevention and cure of cancer.