Clinical Research Coord I

Clinical Research Coordinator I

The Department of Medicine, Division of Nephrology is seeking a full time Clinical Research Coordinator I. This position will participate in all aspects related to coordination of clinical research. This position will work with Division investigators and the clinical trials director and staff to coordinate clinical studies within the Division, both general nephrology and transplant. This includes management of multiple research studies with different schedules and deadlines, including investigator initiated, industry sponsored and government sponsored trials. These trials may be local or multi-centered. This position will be responsible for meeting deadlines, paying attention to detail, protocol requirements, sponsor requirements and IRB deadlines. Must understand and comply with the regulatory policies and procedures regarding human subject research: governmental, state, and as required by this University. Completion of research training as required by the University of Florida and College of Medicine including RAC training, Privacy training, IRB training, and CITI or NIH training. This position will report to the Assistant Director in the Division of Nephrology, Hypertension and Renal Transplantation.

Essential Functions;

• Coordinate with multiple Principal Investigators by facilitating study-related duties, including but not limited to patient recruitment, protocol adherence, and data collection.
• Ensure strict adherence to IRB-approved protocols throughout all stages of the research process.
• Actively participate in the informed consent process, ensuring thorough understanding and compliance from study subjects
• Efficiently coordinate all protocol-related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants utilizing EPIC EMR system and referrals
• Maintain accurate and organized study source documents, ensuring that all essential documents, such as informed consent forms and participant records, are up-to-date, easily accessible, and securely stored.
• Promptly report any adverse events or deviations from the protocol
• Demonstrate a comprehensive understanding of good clinical practice (GCP) and regulatory compliance standards, implementing them rigorously throughout the research process
• Educate subjects and family on protocol, study intervention, study drug, and any relevant procedures

• Ensure strict adherence to institutional policies, standard operating procedures (SOPs), and guidelines, as well as federal, state, and sponsor policies throughout all research activities
• Complete case report forms accurately and promptly, utilizing both paper and electronic data capture methods, and address any queries in a timely manner to maintain data integrity.
• Facilitate pre-study, site qualification, study initiation, and monitoring visits
• Facilitate study close out activities, ensuring smooth coordination and completion of all necessary tasks, including but not limited to final data collection, documentation, and regulatory compliance measures.
• Actively participate in research team meetings, contributing insights and updates on study progress and challenges
• Collect, process and ship laboratory specimens, ensuring proper handling and adherence to study protocols
• Coordinate and manage the scheduling of subject visits and procedures, ensuring adherence to study timelines and protocols
• Retain records/archive documents after study close out, ensuring regulatory compliance and facilitating future reference or audits.
• Actively participate in promoting Human Subjects Protections within Clinical Research areas, advocating for ethical practices and compliance with regulatory requirements to ensure the safety and well-being of research participants.

• Provide back-up coverage for Clinical Research Coordinator II and Nephrology Assistant Director as needed
• Participates in the development and conduct of study billing plans.

$39,700 - $45,000 Annually

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.

Prior experience with clinical research. Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore) EPIC EMR System

"In order to be considered, you must upload your resume." 

This position is time limited. 

Application must be submitted by 11:55 p.m. (ET) of the posting end date.