External Research Quality Manager
Job posting number: #7076684 (Ref:hlj_30034)
Posted: April 2, 2021
Application Deadline: Open Until Filled
Moffitt Cancer Center (MCC), an NCI-designated comprehensive cancer center in the state of Florida, and a top ranked hospital for Cancer on U.S. News & World Report, is seeking highly motivated individuals to join the Clinical Trials Office Partnerships as an External Research Quality Manager. Be part of the significant contributions to the prevention and cure of cancer which is based on compassion for our patients, an emphasis on collaboration, and a culture of scientific excellence.
This position will be responsible for the quality and management of multiple clinical research protocols conducted at multiple research sites locally and nationally for the Sunshine Project. The Sunshine project is a growing consortium of over 20 sites conducting early phase pediatric oncology research funded by the National Pediatric Cancer Foundation.
- Support the mission of the Sunshine Project leveraging novel therapies to treat and eliminate childhood cancer through multicenter collaborative early phase pediatric oncology research projects.
- Perform compliance monitoring activities including:
- Review of source documentation for verification of consent and eligibility of clinical research participants
- Verify regulatory approvals
- Review of case report forms for completeness and accuracy with the medical record
- Determining accurate capture and reporting of participant adverse events
- Maintain OnCore Databases (EDC) and oversees timely data entry.
- 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.
- Aide in development of protocol specific tools and manuals.
- Aide in training of external and internal staff members on protocol specific training and various research compliance related topics.
- Assist with the development and review of informed consent documents.
- Work collaboratively in a cross functional team.
Travel will be required to site initiation visits and monitor data at Sunshine consortium sites. Remote monitoring is promoted.
- Bachelor's degree (Master's preferred)
- Four (4) years clinical research coordination experience including intervention trials.
- Extensive knowledge of clinical research regulations and processes required.
- Monitoring experience
- Pediatric oncology experience
- Multisite coordination experience
- Clinical Research Certification
Mission To create a Moffitt culture of diversity and inclusion as we strive to contribute to the prevention and cure of cancer. Vision Moffitt Cancer Center is recognized as the model wherein the diversity of our employees and communities is valued and supported as essential components to contributing to the prevention and cure of cancer. The cancer center is an equal opportunity employer. It is the policy of the cancer center to prohibit unlawful discrimination and harassment of any type and to afford equal employment opportunities to workforce members and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, genetic information, veteran’s status or any other characteristic protected by federal, state or local law.