Clinical Research Coordinator II

University of Florida•Jacksonville, FL

9d•$55,000 - $65,000

About The Position

Work at UF research locations, across the greater Jacksonville area, prescreening, consenting, and enrolling participants in research studies, including inpatient at UFHealth Work closely with staff in the Institute for Population Health to determine study participant eligibility. Review eligibility and recruitment material; provide and explain enrollment information to research participants. Must have independent transportation to travel to participating study clinics to conduct study visits, check-in visits, recruitment assistance 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. Coordinates and implements follow-up procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources. Carefully review and understand the needs of each study. Report to the study Principal Investigator and IPH leadership on any participant adverse events (AEs) and serious adverse events (SAEs). Create and maintain source documents. Enter data into electronic data capture systems. Enter patient information into OnCore CTMS. Enter orders into EPIC. 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. Update all regulatory information in Veeva eRegulatory system. Process and ship biosamples according to local and federal regulations. Maintain IPHI biobank using the cloud-based LIMS system. Maintain annual temperature calibration of IPH laboratory equipment 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.
Must have independent transportation to travel to participating study clinics

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.
Experience coordinating clinical research studies.
Knowledge of basic principles and good clinical practice of clinical research
Proficient in the use of personal computer software, including Microsoft Office

Responsibilities

Prescreening, consenting, and enrolling participants in research studies, including inpatient at UFHealth
Work closely with staff in the Institute for Population Health to determine study participant eligibility.
Review eligibility and recruitment material; provide and explain enrollment information to research participants.
Travel to participating study clinics to conduct study visits, check-in visits, recruitment assistance 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.
Coordinates and implements follow-up procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources.
Report to the study Principal Investigator and IPH leadership on any participant adverse events (AEs) and serious adverse events (SAEs).
Create and maintain source documents.
Enter data into electronic data capture systems.
Enter patient information into OnCore CTMS.
Enter orders into EPIC.
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.
Update all regulatory information in Veeva eRegulatory system.
Process and ship biosamples according to local and federal regulations.
Maintain IPHI biobank using the cloud-based LIMS system.
Maintain annual temperature calibration of IPH laboratory equipment
Help Investigators with proposal development, progress reports, budget creation, regulatory paperwork, and study files.