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.
