As the 5th largest U.S. city and a growing 40% Hispanic population, the UArizona College of Medicine – Phoenix is uniquely poised to serve as a leader in cutting edge clinical trial opportunities and to serve as a conduit for the community partnerships necessary to aid in researching the health needs of our diverse surrounding communities.

Translational Research Office (TReO) is a college service that provides college-level leadership and organizational support to ensure seamless research education and operations across translational research implementation needs. TReO is designed to serve as an access hub to research expertise and resources for clinical and basic science support. Under the collaborative leadership of the Vice Dean for Clinical Affairs and the Vice Dean for Research, TReO aims to be a catalyst to navigate institutional research processes, reduce inefficiencies and serve our growing research faculty. TReO provides a centralized infrastructure to support investigator and study logistical needs, as well as foster local partnerships to contribute to emerging translational science proposals that can expand access to treatment options that support our surrounding communities.

TReO Clinical Research Services aim to support investigators across college departments throughout the clinical trial process from study development to closure. Our clinical research leadership team assist Faculty in the feasibility, startup and conduct of federal and industry sponsored trials as well as investigator-initiated research. Leadership provides daily operational support, training, and oversight of our centralized clinical research staff, as well as volunteers and students, at at the UArizona College of Medicine –  Phoenix /Banner – University Medical Center Phoenix (B-UMCP).

Our team is instrumental in study start-up processes including assistance with protocol and budget review, execution of research agreements, and facilitation of communications between Industry partners and internal and external research collaborators. Our team works closely with hospital and university leadership to navigate hospital feasibility review, troubleshoot operational issues and other study challenges to ensure timely study startup and ongoing oversight of study progress. Our team meets regularly with Department Chairs to discuss department research portfolios and review research finances.

We provide quarterly enrollment metrics reports to assist in determination of ongoing departmental support. We aim to facilitate research needs and minimize investigator administrative burden through oversight and management of research centralized resources to maximize efficiency and ensure uniform standard operating procedures. Our clinical research resources include:

  • A hub of centralized clinical research coordinators for compliant study conduct
  • Regulatory assistance for IRB submissions, study monitoring and closeout
  • REDCap project development to ensure a HIPAA compliant, electronic data platform for compliant data collection and storage.
  • Biorepository/Data repository collections, processing, transport, and storage
  • Financial management of clinical trial revenues
  • Clinical research designated facilities on B-UMCP hospital campus.

Clinical Research Teams

Clinical Research Coordinator Team

Clinical Research Coordinator Team is a centralized pool of clinical research coordinators that support studies across COM-P departments and divisions. TReO leadership works with each department to assess research staff needs, as well as handle the logistics of hiring and employee supervision on behalf of investigators. Recognizing the need to support study access for our Spanish-speaking community, TReO also maintains a pool of bilingual research coordinators across study teams as well as a racially diverse clinical research coordinator pool to support cultural competency efforts. Coordinators may be assigned to specific departments that maintain an ongoing research portfolio or can be assigned to support individual studies as they arise. This centralized model increases efficiency and compliance, prevents coordinator burnout, and facilitates the ability to respond to a rapid need for clinical trial coordinator support without human resource delays. This model was extremely effective in in our efforts to contribute to the evaluation of potential therapies and reduce the loss of research revenue during the COVID-19 pandemic as coordinators were immediately organized to facilitate rapidly emerging COVID-19 clinical trials. 

Regulatory Compliance Team

Regulatory Compliance Team offers support and expertise to clinical research investigators in navigating the conduct of human subject research and compliance with regulatory requirements.  Our team aids with IRB submissions and communications as well as investigator assistance in navigating Conflict of Interest (COI) disclosures and collaborating with the COI Office to implement COI management plans as required. Our Compliance Auditor conducts internal risk-based audits to assess compliance and determine focus areas for ongoing education. With a goal of facilitating compliance through a culture of continuous education, the Compliance Auditor also organizes monthly brown bag sessions that focus on clinical research practices and pertinent regulatory requirements and provides clinical research education content for Division Newsletters.

REDCap Clinical Data Team

REDCap Clinical Data Team maintains electronic clinical trial documentation in REDCap in effort to support a more secure and paperless environment while maintaining compliance with study-related documentation requirements. The REDCap team offers support in project design and development for both investigator-initiated studies and sponsored clinical trials to enable an ePlatform for all clinical research studies. The team is highly knowledgeable in customized design, advanced branching, and form creation to optimize data collection for statistical analysis. Working in close collaboration with our faculty, resident/fellows, and clinical research teams, databases are customized to meet study protocol requirements and maintain compliance with local, state, and federal guidelines. In addition, the team is proficient in customizing reports within REDCap to satisfy Department/Division, College/University, and state/federal reporting requirements.

Biorepository Team

Biorepository Team is a collaboration between our clinical research coordinating team and COM-P biobank services which operates under a Biobank Committee that is constituted to review project proposals and determine best allocation of resources to support translational research initiatives. In response to IRB-approved requests for the collection of blood, tissues and other fluids across hospital clinics and operating rooms, our teams huddle daily to review potential cases for collection and coordinate specimen collection, transport, and processing within strict timelines to ensure sample integrity. The biorepository lab team maintains a catalog of all available specimens and provides regular reports to the Biorepository Committee for oversight.

Clinical Research Billing Team

Clinical Research Billing Team is responsible for reviewing technical and professional charges for research studies to validate billing for items and services related to clinical trials in compliance with federal regulations, state laws and contractual agreements. Our team also facilitates payment to our hospital, laboratory and other external partners providing research services. In addition, the team also provides quarterly reports to Department Chairs for financial updates.

Clinical Research Facilities

Clinical Research Facilities are conveniently located on campus of our B-UMCP hospital affiliate in the UArizona Clinical Research Suite at the Banner - University Medical Center Phoenix Medical Institute. The 4,101 square foot clinic is designed to provide a centralized hub of research resources to be available for all UArizona Phoenix-related clinical research needs. Services and resources are available below.

Resources Services
  • 4 private exam rooms
  • IV infusion room
  • Bariatric exam room
  • 3 consult rooms
  • Specimen processing room
  • 2 vitals/phlebotomy stations
  • 24-hour continuous temperature monitoring of study drug
  • Clinical trial supply storage
  • Specimen refrigerator
  • -80° freezer
  • Ambient and refrigerated centrifuges
  • Automated blood pressure machines
  • Height and weight scales
  • Study coordination
  • Consenting
  • Recruitment Assistance
  • Study specific REDCap project development
  • Regulatory Submissions
  • IV administration for study infusion therapies
  • Phlebotomy
  • Biospecimen collection and processing
  • PK monitoring
  • EKGs
  • Study monitoring/auditing

College Clinical Research Metrics

As a young college that began investing in clinical research resources in 2014, we strive to ensure sustainable services through lean administrative overhead costs and relying upon clinical trial revenues to reimburse expenses for clinical research coordinator effort and other study related costs. Since our inception, we have had strong growth in our recognition as a clinical research entity to our community. 

Study Portfolios 

With clinical research support services, the college has steadily built a portfolio of sponsored and investigator-initiated studies that continues to grow annually. We support approximately 80 sponsored studies and over 200 investigator-initiated studies each year. Cardiology is our strongest department in sponsored research with approximately 50% of all college studies and with a strong focus in investigative device implantation and early feasibility/first-in-man trials. Ob/Gyn has the largest portfolio of investigator -initiated studies with over 25% of total study volumes and a strong focus on collaborative projects involving residents and fellows.

Subject Demographics

We have enrolled over 6,000 participants in various prospective research studies with great effort to be inclusive of our surrounding demographic populations.  Our enrollments include an average of 4% Native American, 7% African American and 27% Hispanic populations, which is also reflective of the composition of our study coordinating teams. Our prospective studies collectively average a 66% female population, which can be attributed to our research portfolio in support of women’s health.

More information or questions, Email: COMPHX-Cress@email.arizona.edu