Clinical Research Coordinator II

University of Florida•Jacksonville, FL

2d•Onsite

About The Position

The Clinical Research Office (CRO) in the Office of Research Affairs (ORA), Dean’s administration, College of Medicine-Jacksonville is looking for a Clinical Research Coordinator II to assist coordinating, engaging and performing research and regulatory functions for clinical research studies. The CRC II will screen and consent patients in different clinics and will conduct research visits as required by the research protocols. He/she will perform functions necessary for successful completion of all protocols including but not limited to required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with protocol/sponsor requirements. This position will work on clinical research studies across many different disciplines, interacting with numerous research teams from the inception of a clinical trial though the close out. Work independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation. Submission of protocol, consent documents for IRB approval and assist in preparing regulatory submissions as requested Work at UF research locations prescreening, consenting and enrolling participants in research studies. Conduct study visits and follow ups including functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks as needed. Help Investigators with proposal development, progress reports, budget creation, regulatory paperwork and study files

Requirements

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Valid Driver’s license

Nice To Haves

Master'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.
Experience in phlebotomy and clinical research.
Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
Coordinates multiple tasks and work independently and productively in a fast paced, deadline-oriented environment.
Proficiency in data management and organization skills.
Integrity, careful attention to detail; ability to maintain confidentiality, demonstrate professionalism and respect for subjects’ rights and individual needs; willing to learn and maintain skills in accordance with HIPAA regulations and Good Clinical Practice guidelines.

Responsibilities

Screen and consent patients in different clinics.
Conduct research visits as required by research protocols.
Perform functions necessary for successful completion of all protocols including required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks.
Coordinate all necessary activities required to set up and monitor a study.
Complete accurate study status reports.
Maintain study documentation.
Submit protocol and consent documents for IRB approval.
Assist in preparing regulatory submissions.
Prescreen, consent and enroll participants in research studies.
Conduct study visits and follow ups.
Help Investigators with proposal development, progress reports, budget creation, regulatory paperwork and study files.