Clinical Research Coord I-Transplant Center

University of Florida•Gainesville, FL

1d•Onsite

About The Position

Seeking qualified candidates for a Clinical Research Coordinator I (CRC I) position within the Transplant Center, Department of Surgery, Division of Transplant Surgery under the direction of the Investigator. As part of an interdisciplinary health team, the incumbent will collaborate with other CRCs, physicians, nurses, and other key personnel in the department and clinic to ensure compliance with protocol requirements and satisfactory care for enrolled patients. The incumbent will also assist in the development of protocol methodologies and data collection.

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

Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
Experience as a research coordinator preferred.
Experience with patient data and/or databases.
Proficient time management skills and ability to successfully manage multiple studies.

Responsibilities

Perform subject screening and consent for clinical protocols under direction of the Principal Investigator (PI)
Serve as patient resource and educator for information regarding the study and/or clinical symptoms.
Prepare and ship central laboratory samples as per protocol requirements.
Collect baseline and follow-up data from the medical record.
Document findings in appropriate source records and case form reports.
Schedule and attend clinic appointments for patients as required by protocol.
Assist with operating room protocol requirements where appropriate.
Maintain knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulation regarding clinical trial conduct.
Coordinate and maintain HIPAA compliance for assigned studies.
Communicate with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
Interact with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.
Coordinate efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.
Assist medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.
Help with protocol development and endpoints to ensure statistical and clinical relevance of studies.
Assess clinical needs by performing literature review and discussion with faculty advisors within the Division.
Prepare and submit filings of protocols to the Investigational Review Board (IRB) and Animal Care Committees as needed.
Design Case Report Forms and Source Documents for clinical protocols where required.
Assist with grant development projects as needed for preclinical studies with the Division.
Assist with manuscript preparation and abstract submission for PIs.
Track the type of study services performed to ensure that they are compensated appropriately.
Other duties as assigned.