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

The University of Arizona Cancer Center (UACC) is a National Cancer Institute-designated Comprehensive Cancer Center committed to preventing and curing cancer through exceptional patient care, groundbreaking research, and comprehensive education.

The clinical research coordinator III is responsible for consenting, screening and coordinating collection and submission of data, and follow up for all patients on assigned clinical trials. The coordinator serves as the liaison between the regulatory staff, research RNs, clinic staff and physicians and research sponsor to carry out the required events determined by the protocol calendars including data entry. Each coordinator works on Investigator Initiated Trials (IITs), sponsored studies and National Clinical Trial Network studies (NCTN) ranging from phase 1-4 with varying complexities. The coordinator is involved from the time of the site evaluation visit, site initiation visit and start up 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.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to UA recreation and cultural activities; and more!

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Act as the primary Clinical Research Coordinator for Oncology Clinical Trials:

• 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.

Support the Orientation and Training of New Team Members:

• 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 UArizona 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 on-boarding 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.

Perform Data Management Tasks:

• 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.

Perform Clinical Research Coordination tasks individually and with a team.

• 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

Maintain Proper Communication Across Study, Clinical and Research Staff:

• 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 UArizona and our Clinical Partner.

Other tasks as assigned

Knowledge, Skills, and Abilities:

• Demonstrated strong interpersonal, communication, and problem-solving skills.
• Demonstrate leadership qualities when working in a team setting.
• Excellent organizational skills.
• Attention to detail.
• Ability to multitask using time management skills.
• Comfortable with navigating electronic databases and data management.

• 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.
• Knowledge and experience in clinical research, preferably in Oncology.
• Extensive knowledge of clinical research coordination, compliance and GCP requirements, and data management expertise, preferably in Oncology.
• Certified in Clinical Research (ACRP or SOCRA or equivalent) or willing to pursue certification.