Job Summary
- Assists Principal Investigator (PI) and participates in protocol development, evaluation, and review of risk assessment; evaluates study design and risk to subject population; determines staff, facility, and equipment availability; assesses study population/availability.
Designs recruitment strategies for each assigned study; recruits subjects according to Institutional Review Board (IRB)/protocol approved methodologies; consents subjects including discussion of treatment and intervention alternatives; monitors enrollment goals and modifies recruitment strategy as needed.Liaisons with health-care professionals/providers to determine best recruitment practices for study; manages subject recruitment including marketing, screening procedures, and enrollment.Ensures proper collection, processing, shipment of specimens, and documentation; communicates with laboratory, PI, and sponsor regarding laboratory findings; records and documents protocol deviations; communicates with PI and sub-investigators about changes in the trial.Participates in preparation and negotiation of study budget and reconciles study budget accounts.Reviews, critically evaluates, and comments upon study contracts/agreements.Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary).Schedules study-related meetings and training sessions and provides instruction to study team for specific study assignments; educates staff regarding scientific aspects of study and trains ancillary staff regarding clinical studies or trials; monitors study team compliance with required study procedures and Good Clinical Practice (GCP) standards.Manages research study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation.Composes and submits continuing review/amendments/close out information; schedules and prepares for monitor visits; prepares and responds to Sponsor and/or FDA audits.Stays up-to-date and maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings. 
