Clinical Research Coordinator II, Family and Community Medicine (Multiple)

Clinical Trial Patient/Participant Coordination Coordinate clinical trial recruitment, including study participant recruitment, screening/interviews, evaluation of potential participants, obtaining informed consent, and subject data collection. Conduct protocol-dependent research activities. Serve as a resource for patients and families regarding study-related concerns and information. Create and prepare recruitment, retention, education, and training materials for patients, families, and clinical staff to assure patient safety, retention, and adherence to protocols. Administer and assist in the proper collection, processing, storage, and transport of biological specimens and ensure their handling. Mentor and train new staff in in preparation and conduct of clinical trials. Duties may be performed at rural areas/sites across the state of AZ. May require occasional evening, overnight, and/or weekend travel. Research, Protocol Data Management Provide input into the design, development, execution, and initial interpretation of clinical trial protocols, treatment plans, compliance forms, and tracking documents. Conduct research and literature reviews to assist the Principal Investigator in designing appropriate research methodologies, techniques, and procedures. Participate in data-management design and maintenance. Enter, manage, and maintain study data in accordance with Good Clinical Practice (GCP) standards. Support development and preparation of Human Subjects documentation for NIH and other federally funded grant applications. Regulatory, Compliance Institutional Coordination Prepare, coordinate, and maintain regulatory documentation, including Institutional Review Board (IRB) submission and approval of new or revised protocols, safety reports, and progress reports. Collect and submit required documentation to the IRB, University, and corporate or government sponsors. Ensure research activities and documentation comply with applicable protocols, GCP requirements, and institutional/regulatory standards. Coordinate compliance-related documentation and tracking throughout the life of clinical trials. Research Portfolio, Financial Operational Administration Develop administrative and financial recommendations for department management and PIs for research portfolio review. Conduct quarterly reviews and strategic analyses of PI research portfolios and accounts. Order and maintain study supplies and kits. Track study-related spending and make day-to-day operational decisions supporting studies. Coordinate administrative aspects of research activities and provide operational support to PIs and study teams. Knowledge, Skills, and Abilities: Knowledge of the principles, practices, and techniques of research clinical skills. Ability to provide high quality, compliant research. Skill in maintaining detailed records. Desire to build new program and develop new policies. Ability to work both independently and with a team, resolving issues with a positive outcome. High level of integrity, ethics and professionalism. Strong communication and computer skills. Strong organization skills and significant attention to detail for data entry. Ability to travel to rural areas areas across the state of AZ. May require occasional evening, overnight, and/or weekend travel. Must have a valid driver’s license and ability to drive according to the University Fleet Safety Policy.