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

The clinical research coordinator 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, site initiation visit, and start-up, through study closure.

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• Act as the primary Clinical Research Coordinator for Oncology Clinical 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.
• 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.
• Participate in Site Evaluation Visits (SEV), Site Initiation Visits (SIV), monitoring visits and audits for Investigator Initiated trials (IITs), sponsored studies and cooperative group trials.
• Participate in and help create trainings and attend required staff meetings. This includes training from the Clinical Trials Office, University of Arizona, Banner and Sponsors to stay informed of processes and procedures.
• Willing to be trained in phlebotomy and/or vitals collection through our clinical partner.
• 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.
• 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.
• 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 U of A and our Clinical Partner.
• Other tasks as assigned.

Knowledge, Skills & Abilities:

• Demonstrated strong interpersonal, communication, and problem-solving skills.
• Strong organizational skills with attention to detail.
• Ability to manage multiple tasks effectively using sound time-management skills.
• Ability to navigate and utilize electronic databases efficiently.

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 3 years of relevant work experience, or equivalent combination of education and work experience.

Experience working or volunteering directly with patients in a healthcare setting.

• Experience or working knowledge of clinical research, preferably in Oncology.