Clinical Research Coordinator III, Clinical Trials (College of Medicine- Phoenix)

Study Coordination Participate in protocol development by reviewing potential protocols, informed consent documents, study budgets, and evaluating their effect on standard clinical research procedures. Prepare and maintain 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 the 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 the study protocol. Monitor participants for evidence of study-related adverse events. Document study participants’ progress in the electronic medical record. Maintain subject data and address study-specific data queries promptly. Adhere to all relevant regulations, including ICH, 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 training (e.g., University of Arizona training, departmental training, study-specific training, etc.). Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multicenter trials. Ensure proper collection, processing, storage, transport, and handling of biological specimens. Administrative and Team Lead Responsibilities Assist the Principal Investigator in developing clinical trial protocols and submitting the required documentation to the Institutional Review Board, the University, and corporate or government sponsors. Develop and maintain 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 the physician and/or Principal Investigator with the preparation of study data/materials for publication and/or presentation of materials at conferences. Actively participate in clinical research team meetings. Provide oversight and strategic direction for assigned studies, ensuring protocol adherence, recruitment effectiveness, and regulatory compliance, while coordinating the efforts of supporting team members as needed. Assign tasks and monitor the performance of junior coordinators to ensure alignment with study objectives and timelines. Develop and implement training materials for new staff members, emphasizing patient safety, ethical considerations, and protocol-specific elements. Study Communications and Education Prepare and present study materials to members of the interdisciplinary team regarding general research procedures and study-specific elements of a protocol. May train new staff in the preparation and 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. Help develop strategies to ensure increased study awareness and subject screening and enrollment. Quality Assurance Monitor study progress, including patient enrollment, data collection, and adherence to study protocols. Perform quality checks to ensure data integrity and identify issues requiring corrective action. Compile and analyze data related to research management activities. Knowledge, Skills, and Abilities (KSAs): Excellent written and verbal communication skills. Ability to collaborate with physicians, study sponsors, and other stakeholders. Advanced clinical research knowledge. In-depth understanding of clinical research protocols, Good Clinical Practice (GCP), and regulatory requirements (FDA, IRB, guidelines). Strong knowledge of informed consent processes, ethical guidelines, and patient confidentiality standards. Ability to handle complex or high-risk patient interactions with empathy and professionalism. Skilled in leadership and team collaboration. Ability to train and mentor junior coordinators and research assistants. Skilled in problem-solving and critical thinking. Time management and organizational skills. Ability to provide high-quality, compliant research.