Submission of protocol, and consent documents for IRB approval, and assist in preparing regulatory submissions as requested
Obtain informed consent; communicate with potential study participants through community lectures, health fairs, etc.; and participant retention as needed.
Work closely with the department leadership and other study staff to determine study participant eligibility.
Review eligibility and recruitment material; educate and provide enrollment information to research participants.
Conduct study visits for multiple protocols and follow-ups, including functions necessary for successful completion.
Report to the Principal Investigator and Clinical Research Manager any participant adverse events (AEs) and serious adverse events (SAEs).
Must have independent transportation to travel between multiple UF Health and research sites across the greater Jacksonville area to conduct research activities, prescreening, consenting, and enrolling participants in research studies.
Coordinates and implements enrollment and follow-up procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources.
Perform blood draws as needed at various time points in clinical trials. Assess and report patient reactions to clinical staff and PI. Perform vitals, collect specimens, and provide patient care per study protocol. Manages tests, procedures, and equipment per protocol requirements.
Process blood samples in the biomedical lab
Package and ship biospecimens to the appropriate site
Responsible for assisting Investigators with progress reports, regulatory paperwork, and study files.
Serve as a backup for master research participant schedule coordination, notification of necessary parties, greeting, and check-in/check-out participants.
Perform phone screening and documentation, data entry, and IRB-related clerical duties.
Make reminder calls and send reminder letters to study participants.
Update participant tracking logs as needed.
Serve as back-up to answer the main phone line and assist with front desk duties.
Other duties as assigned by CRO/ORA leadership