Clinical Research Office
The Clinical
Research Office (CRO) coordinates activities and provides oversight for
clinical research studies conducted by cancer center members. The CRO is located on the 4th floor of the
cancer center and it is formed by the Therapeutics Research Office (TRO), the
Prevention Research Office (PRO) and the Recruitment Office (RO). It works in
close collaboration with the Regulatory Affairs Office (RAO) and the
Informatics services. Specifically, the objectives of the Shared Resource are
to:
- Facilitate protocol activation and give protocol support to
cancer-related research studies
- Facilitate training of relevant clinicians and research staff regarding
protocol parameters
- Facilitate protocol management and conduct of therapeutic, prevention and
intervention trials
- Promote awareness and facilitate dissemination of information about
active clinical trials to cancer center healthcare providers and investigators
- Facilitate screening/enrollment of potential candidates onto clinical
trials
- Provide central informatics services and accurate reporting for cancer
center clinical research protocols
- Generate an adequate protocol portfolio targeting the existing patient
population and prioritizing by protocol type (investigator initiated, national
cooperative groups and industry sponsored)
- Perform quality assurance, research compliance and adherence to GCP
through internal or external auditing and monitoring as appropriate
- Comply with mandatory protocol listing/reporting to the general public
SERVICES PROVIDED
- Supports protocol activation including submission for CRAC, CTPRMC and
IRB review
- Supports training of relevant clinicians and personnel
regarding protocol parameters
- Informed consent process
- Eligibility verification
- Registration and randomization
- Coordination of all required interventions throughout subject
enrollment, (either therapeutic, preventative or intervention
trials)
- Ensures drug accountability through research pharmacists
- Coordinates study procedures with clinic nurses
- Accurate recording and reporting of clinical outcome and
toxicityon OnCore
- Preparation and assistance of internal and external monitoring,
as well as internal and external reporting for CCSG
compliance and internal strategic planning
- The office management team facilitates analysis and decision
making at different levels of protocol review and prepares
technical support for Disease Oriented Teams
FURTHER INFORMATION
To view the Clinical Resource Office flyer click here.
Director: TBN
Phone:
Facility Manager: Margarita
Torres
Phone: 714.456.6907
Finance Manager: Jacqueline
Orozco
Phone: 714.456.6318
Location: Chao Family Comprehensive Cancer Center, 4th Floor, 101 City
Drive, UC Irvine Medical Center, Orange, CA 92868