Clinical Research Coordinator III

University of Florida•Gainesville, FL

23h•$60,000 - $82,000

About The Position

The Clinical Research Coordinator III position described herein 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 position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator III will coordinate assigned clinical research studies independently. The Clinical Research Coordinator III will 1. Onboard new clinical studies following institutional workflows and requirements; 2. Obtain and maintain regulatory compliance; 3. Verify study-related charges following institutional and departmental timelines; 4. Serve as point of contact for all administrative matters related to assigned studies; 5. Enroll patients into assigned clinical studies; 6. Coordinate patient and study monitor site visits; 7. Present study updates at weekly team meetings; and 8. 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: Activities include and are not limited to: 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: Activities included but are not limited to: 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; assuring that the clinical research trial's integrity and quality are maintained and that the trial is conducted following Good Clinical Practice guidelines; attending UF-IRB 01 full board meetings as necessary. Miscellaneous Activities: Activities include but are not limited to: 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. Any other duties, as needed, to fulfill the mission and to abide by the values of the College of Medicine.

Requirements

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

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

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
Actively participate in the writing of grants, papers, etc.
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
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
Assuring that the clinical research trial's integrity and quality are maintained and that the trial is conducted following Good Clinical Practice guidelines
Attending UF-IRB 01 full board meetings as necessary
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
Any other duties, as needed, to fulfill the mission and to abide by the values of the College of Medicine