Clinical Research Coordinator I - Pediatrics CHRI

Pediatrics CHRI•Gainesville, FL

11h

About The Position

The Clinical Research Coordinator I position described herein will coordinate simple clinical research studies and assist in the coordinator of complex 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 simple clinical trials and assisting more experienced coordinators managing complex clinical research studies. The Clinical Research Coordinator I position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator I will coordinate assigned simple clinical research studies while simultaneously assisting senior team members on more complex clinical research studies. The Clinical Research Coordinator I must be able to perform the following essential functions independently: Coordinate clinical research studies 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 for clinical studies managed and assisting. 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,WCG, etc) organizations as required; completing end of study procedures; scheduling and participating in sponsored research monitoring visits; assuring that the clinical 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. Assist senior team members on more complex clinical research studies. Assisting research manager and other team members with regulatory submissions as needed. Miscellaneous Activities Activities include but are not limited to: 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.

Requirements

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Nice To Haves

Bachelor's Degree
Knowledge and experience with clinical trial research process and policies
Proficiency in all Microsoft Office applications
Ability to communicate effectively both verbally and in writing
Excellent interpersonal skills
Prior experience of direct patient contact preferred
Prior experience working with inherited muscular diseases

Responsibilities

Onboarding new clinical studies following institutional workflows and requirements
Obtaining and maintaining regulatory compliance
Verifying study-related charges following institutional and departmental timelines
Serving as the point of contact for all administrative matters related to assigned studies
Enrolling patients into assigned clinical studies
Coordinating patient and study monitor site visits
Presenting study updates at weekly team meetings
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,WCG, 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
Assisting research manager and other team members with regulatory submissions as needed
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