The Clinical Trials Manager -North Florida provides strategic planning, growth, and development for Clinical Research conducted at Nemours Children's Health in Jacksonville. The incumbent supervises and coordinates the responsibilities of research nurses and staff conducting studies and oversees the management of all clinical research projects conducted at Nemours Children's Health- Jacksonville. This role will Serve as liaison between Principal Investigators and ancillary departments, including the Office of Sponsored Projects, Wolfson Children's Hospital, Clinical Research Center, and other pertinent stakeholders.

A. Strategic Planning and Development:
1. Meet with the medical staff and faculty on a regular basis to assess their needs pertaining to clinical trials research.
2. Provide direct oversight to the research team on all research processes pre- and post-award, including the administration and management of clinical trials i.e. federal, foundation, industry-sponsored and individual investigator-initiated trials.
3. Develop goals and performance measures in conjunction with the medical faculty to ensure growth and development of the clinical trials program.
4. Meet regularly with the Associate Administrator - Florida to provide feedback on new initiatives, performance of on-going initiatives, and seek feedback for future programmatic development.
5. Assist with budget management of the clinical trials program.
B. Supervision and Oversight:
1. Supervise and coordinate the daily activities of the research coordinators and staff.
2. Provide guidance and oversight for submissions to scientific and ethical review committees.
3. Review new research protocols and ensure there is adequate and appropriate staffing for current and planned protocols.
4. Conduct interviews and make hiring recommendations.
5. Provide oversight, periodic review including rounding, and feedback to clinical trials staff.
6. Provide procedures for systematic record keeping, drug accountability, patient interactions, equipment tracking, and good clinical practices.
7. Provide pre-review prior to external audit or investigations.
8. Responsible for performance management of designated staff.

Qualifications:

• Masters degree preferred; bachelors degree with appropriate experience may be acceptable.
• BSN with active Florida Nursing License preferred
  Five years of Clinical Research Coordinator experience or equivalent experience required.
• Certified in BLS
  Certified Clinical Research Coordinator (CCRC) preferred