Study Coordination:

• Participate in protocol development by reviewing potential protocols, informed consent documents, study budgets, and evaluate their effect on standard clinical research procedures.
• Assists in the preparation and maintenance of all regulatory documentation including IRB submissions, consent forms, study amendments, safety reports etc.
• Recruit study participants, schedule appointments, interview and evaluate potential participants to ensure they meet eligibility requirements; instruct participants concerning protocol and obtain informed consent.
• Coordinate multiple clinical trials simultaneously.
• Schedule and/or coordinate the scheduling of required laboratory tests and/or exams.
• Coordinate and/or perform physical assessments, lab draws and/or diagnostics as required by study protocol.
• Monitor participants for evidence of study related adverse events.
• Document study participants’ progress in electronic medical record.
• Maintains subject data and addresses study specific data queries promptly
• Adheres to all relevant regulations including ICH and CFR and GCP guidelines, as well as the University of Arizona policies and procedures.
• Assist in the development of databases and participant trackers needed to capture specific protocol required data.
• Remain up to date on all required trainings (E.g. University of Arizona trainings, Departmental trainings, study specific trainings, etc.)
• Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• Ensures proper collection, processing, storage, transport, and handling of biological specimens.

Administrative Responsibilities:

• Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, and corporate or government sponsors.
• Develops and maintains protocol information and data/collection tools.
• Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of the study.
• Assist physician and/or principal investigator in preparation of study data/materials for publication and/or presentation of materials at conferences
• Actively participate in clinical research team meetings.

Study Communications and Education:

• Prepares and presents study materials to members of the interdisciplinary team regarding general research procedures and study specific elements of a protocol.
• May supervise and train new staff in preparation & conduct of clinical trials by providing oversight and guidance.
• Provide ongoing study specific training to other staff members to assure patient safety and adherence to the protocol.
• Helps develop strategies to ensure increased study awareness and subject screening and enrollment.
• Additional duties as assigned.