Clinical Research Coordinator III

Clinical Research Coordinator III

The Clinical Research Coordinator III position will coordinate clinical research studies in the Department of Pediatrics - Child Health Research Institute. All clinical studies will focus on inherited muscular diseases. The incumbent will be responsible for coordinating all aspects of assigned clinical trials.

The Clinical Research Coordinator III will:

• Onboard new clinical studies following institutional workflows and requirements;
• Obtain and maintain regulatory compliance;
• Verify study-related charges following institutional and departmental timelines;
• Serve as point of contact for all administrative matters related to assigned studies;
• Enroll patients into assigned clinical studies;
• Coordinate patient and study monitor site visits;
• Present study updates at weekly team meetings; and
• Actively participate in the writing of grants, papers, etc.

The Clinical Research Coordinator III must perform all clinical research activities independently and is responsible for coordinating assigned clinical trials. The Clinical Research Coordinator III will ensure research across the clinical trial life cycle. The Clinical Research Coordinator III will be assigned to manage multiple complex clinical trials at once.

The Clinical Research Coordinator III must be able to perform the following essential just functions independently for multiple ongoing clinical trials:

• Serve as study coordinator for clinical trial protocols as assigned:
• Recruiting patients to enroll in study(ies);
• Coordinating patient visits;
• Managing patient visits in accordance to protocol;
• Coordinating site monitor visits;
• Submitting necessary compliance paperwork;
• Ensuring billing compliance;
• Resolving issues/questions with the sponsor;
• Serving as the liaison between the Principal Investigator and study subjects;
• Performing study feasibility assessments for potential new studies.
• Clinical trial regulatory compliance management:
• Initiating and maintaining a current regulatory file;
• Preparing and submitting documents related to clinical trials to both internal (UF-IRB, UF-OCR, UF-IBC, etc.) and external (FDA, RAC, WIRB, etc) organizations as required;
• Completing end of study procedures;
• Scheduling and participating in sponsored research monitoring visits;
• Assurance that the clinical research trial's integrity and quality are maintained and that the trial is conducted following Good Clinical Practice guidelines; and
• Attending UF-IRB 01 full board meetings as necessary.
• Miscellaneous Activities:
• Providing clinical study updates at team meetings;
• 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.

Expected Salary: $60,000 - $82,000; commensurate within this range based on qualifications and experience

Required Qualifications: Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Preferred: 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.

Special Instructions to Applicants: To be considered for this position, please upload your cover letter or letter of interest, resume, and a list of professional references. Full-time, Monday through Friday, 08:00 AM to 05:00 PM, nights & weekends as needed for on-going research. This is a time-limited position. Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes