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Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.

Summary

Job Summary:

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 over 20 sites including Moffitt Cancer Center. Staff in this position will be responsible for the following:

Review of Sunshine Trials during the Scientific Review Process (initial submissions and amendments) 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 of Sunshine Trials, including but not limited to verifying all regulatory approvals and reviews case report forms for completeness and accuracy with the medical record. Determines accurate capture and reporting of participant adverse events and serious adverse events, ensures compliance research activities with the approved research protocol, Good Clinical Practice Guidelines (GCP), federal regulations, and provides a thorough report of findings, identifying trends and providing recommendations to correct and/or improve processes. Presents findings to the Principal Investigator, study team, and Sunshine team with recommendations for corrective actions, including but not limited to correction of data, reporting of deviations, adverse events, and serious adverse events, or amending the study for clarification or correction. Maintains OnCore databases and oversees data entry by sites. Reviews Serious Adverse Events (SAEs) and protocol deviations for accuracy and completeness of information. Collaborates with colleagues of the Sunshine Project team to prepare for external and/or internal audits as necessary. Aides in the training of external and internal staff members on various research compliance related topics. Serves as a resource providing education
and training to sites utilizing study manuals and Good Clinical Practice Guidelines. Assists with the development and review of Informed Consent Documents. Develops study specific OnCore manuals for research sites. Participates in regularly scheduled cross-functional study team meetings with internal and external resources. Assists with the development of agenda items and presentations at the annual Sunshine Summit meeting. Reviews source documentation for verification of consent and eligibility of clinical research participants prior to trial registration. Provides feedback in real time to treating physician and research staff if unable to verify eligibility according to trial, GCP and study site policies.

 

Minimum Experience Required:

Bachelors Degree Required

4 years clinical research coordination experience including intervention trials. Extensive knowledge of clinical research regulations and processes are required. Must have ability to establish and maintain effective, collaborative working relationships with others. Ability to clearly communicate verbally and in writing. Must have excellent organizational skills and careful attention to details. Must be able to communicate and work productively with all levels of administrators, faculty, staff and the public. Strong database management and overall computer skills.

Preferred:

Masters Degree Preferred

5 years of clinical research coordination experience; 2 years in monitoring of clinical trials; 2 years in multisite research coordination. Knowledge of clinical research in the pediatric population