Clinical Research Coordinator III, University of Arizona Cancer Center (Full-Time)

The clinical research coordinator III is responsible for consenting, screening, and coordinating the collection and submission of data, and follow-up for all patients on assigned clinical trials. The coordinator serves as the liaison between regulatory staff, research RNs, clinic staff, physicians, and the research sponsor to carry out the required events outlined in the protocol calendars, including data entry. Each coordinator works on Investigator Initiated Trials (IITs), sponsored studies, and National Clinical Trial Network (NCTN) studies, spanning phases 1-4 and varying in complexity. The coordinator is involved from the site evaluation visit and site initiation visit through start-up, and all the way to study closure. Utilizing their knowledge of clinical research, the CRC III also assists in the orientation and training of new team members, as well as ongoing training and compliance checks.

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• Coordinate the patient care requirements of IRB approved clinical trials protocols. This includes consenting, screening, registering, re-consenting, scheduling appointments and procedures, creating documentation, and submitting data.
• Works with a team to create plans to confirm proper execution of clinical trial study procedures.
• Act as the primary contact for Site Evaluation Visits (SEV), Site Initiation Visits (SIV), monitoring visits and audits for Investigator Initiated trials (IITs), sponsored studies and cooperative group trials.
• Able to work at one of a few Arizona Cancer Center locations including the Main Cancer Center, the North Cancer Center Clinic, Orange Grove Clinic, or others as assigned.
• Demonstrate professionalism and apply basic leadership practices.
• Participate in trainings including creating and presenting material.
• Contribute as a leader and peer-mentor within CTO supporting management on various tasks and responsibilities as appropriate.
• May be the primary contact for process improvement meetings within the U of A and our clinical partner.
• May sit on or lead a committee to help improve clinical trials office processes and procedures.
• Assist in the creation of work-practice documents.
• Develop or contribute to the development of tools, processes, and trainings to enhance the administration and execution of clinical trials.
• Act as a preceptor for staff members including but not limited to assisting in the onboarding of new staff including support staff and other clinical research coordinators.
• Act as domain expert with breadth of knowledge in all trial phases (pilot, 0, I, II, III), trial type (Industry, National, IITs) and ability to cross-cover clinical research teams.
• Following ALCOA-C guidelines, all data collected must be attributable, legible, contemporaneous, original and accurate.
• Gain access to all associated clinical trail data management systems and confirm all necessary staff also have access.
• Ensures proper data collection and submission of data into the appropriate data management systems including our local clinical trials management system, the electronic medical record system and specific electronic data capture systems.
• Evaluate tumor response with Response Evaluation Criteria in Solid Tumors (RECIST) and other evaluation criteria used in Oncology.
• Collect appropriate signatures to stay in compliance with GCP.
• Follow up on monitoring report action items and queries in a timely manner.
• Lead assigned Clinical Research Team to confirm data management is distributed equally and is completed timely.
• Acts as primary coordinator to meet the time points of assigned clinical trial calendars.
• Instructs and counsels patients and family members in research procedures. This includes assisting with giving report to pharmacy and infusion nurses for clarification on each specific patients' status on each protocol.
• Work with pharmacokinetic coordinators to collect fresh biopsy collection and participate in the processing and shipment of samples when necessary.
• Monitor site compliance with subject safety reporting, escalate issues and develop or contribute to the development of tools, processes, and trainings to enhance subject safety during the conduct of clinical studies (Corrective Action, Preventative Action reports - CAPA, and other internal documents to assist with team structure)
• Willing to be trained in phlebotomy and/or vitals collection through our clinical partner.
• Constant communication is required between clinic staff, research RNs, pharmacokinetic team members, study monitors, physicians and patients.
• Patients must be regularly informed of their appointments and research specific requirements (example: additional visits for blood draws and other biological specimen submissions).
• Act as primary contact for all assigned clinical trials for study monitors, physicians and other staff including finance representatives from the U of A and our Clinical Partner.
• Other tasks as assigned.

Knowledge, Skills & Abilities:

• Demonstrated interpersonal, communication, and problem-solving skills.
• Ability to demonstrate leadership and collaborate effectively in a team environment.
• Strong organizational skills with attention to detail.
• Ability to manage multiple tasks effectively using sound time-management skills.
• Ability to navigate electronic databases and perform accurate data management.

This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve.

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Minimum of 5 years of relevant work experience, or equivalent combination of education and work experience.

• Experience working or volunteering directly with patients in a healthcare setting.
• Clinical Research certification (ACRP, SOCRA, or equivalent), or willingness to obtain certification.
• Previous experience or exposure to clinical research environments, preferably in oncology.
• Prior involvement with clinical research coordination activities, regulatory compliance, Good Clinical Practice (GCP) standards, and data management, preferably in oncology.