Clinical Research Coordinator III - Child Health Research Institute

University of Florida • Gainesville, FL

5d • Onsite

About The Position

The Clinical Research Coordinator III position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator III will coordinate assigned clinical research studies under minor supervision while simultaneously working as part of the group mentioned above.

Requirements

• Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
• Proficient knowledge of FDA, NIH, and federal and local policies for research protocols.

Nice To Haves

• Knowledge and experience with clinical trial research process and policies.
• Excellent interpersonal skills; ability to work independently, solve problems and make appropriate decisions.
• Ability to communicate effectively both verbally and in writing.
• Proficiency in all Microsoft Office applications.
• Knowledge of UF and College of Medicine policies and procedures.
• Experience of direct patient contact preferred.
• Experience working with inherited muscular diseases.

Responsibilities

• Serve as primary study coordinator for clinical trial protocols as assigned: Activities include but are not limited to: Onboarding new clinical studies following institutional workflows and requirements; Assisting PI and Clinical Research Manager with subject identification, recruitment, and enrollment. Takes primary responsibility for creation and maintenance of regulatory documents, including initial IRB submissions, continuing review submissions, and FDA and sponsor regulatory documents. Assists in the development of the study budget. Schedule, perform and or coordinate all study procedures / visits across all disciplines. Ensure that GCP is maintained throughout the length of the study. Host / prepare for external and internal audits (sponsor, FDA, NIH, IRB, etc.) Responsible for the protocol specific training of research and clinical staff involved in the study. Development of protocol specific case report forms as needed. Maintain and coordinate all aspects of complex study conduct, including data source documentation, adverse event reporting, and communication with the IRB / sponsor. Ensure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management / EDC system in a timely fashion. Manage / correct all CRA / sponsor queries in a timely fashion. Reviews and verifies that all trial related charges are billed to the project and maintains study related SharePoint folders. Works with administrative and clinical offices on obtaining invoices for trial services and verifying accuracy of received invoices. Assists with development of policies and best practices Proficient knowledge of FDA, NIH, and federal and local policies for research protocols. Attends conferences / meetings as a representative of the CHRI. Present study updates at bi-weekly team meetings.
• Coordinates activities related to development and operation of the various clinical trials / research in gene therapy and grant proposals. Such activities may include: coordination of collaborative research efforts among members of the program; organization and writing of protocols and grants, coordination with UF’s Institutional Review Board, the Western Institutional Review Board, IACUC, General Clinical Research Hub as well as the Division of Sponsored Research. Position will assist the Program Director and the Clinical Research Manager in evaluating program operation based on criteria of efficiency and effectiveness and will modify, suggest and/or implement policies and procedures as necessary.
• Miscellaneous Activities: Activities include but are not limited to: Providing clinical study updates at team meetings; Perform outreach duties for the program, including but not limited to : preparing and giving presentations about program or portions of the program for UF audiences; preparing and giving presentations about the program or portions of the program to the general public including community groups, school groups, scientific meetings, and potential financial investors / donors; assist in the design of program related print promotional and educational materials for public distribution; other outreach activities as opportunities arise. Completing tasks as assigned to complete clinical trial(s); satisfying annual competencies as required by the University of Florida and Institutional review boards; participating in professional development and continuing education. Any other duties, as needed, to fulfill the mission and to abide by the values of the College of Medicine. These duties may involve travel.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level