Clinical Research Support Office/CRSO
The mission of the Clinical Research Support Office (CRSO) as recipient of an Clinical Translational Science Award is to provide comprehensive, coordinated resources, education, and services to the Rockefeller clinical research community, community partners, and human research participants in a manner that is integrated across the entire research enterprise, so that research is conducted to the highest standards of safety and ethics, and at the highest standards of scientific design and integrity.
The Regulatory Knowledge and Support Key Function of the Rockefeller University Center will be served by the Clinical Research Support Office (CRSO), offering a broad range of services, policies, direct assistance, education, advocacy, resources, and tools for members of the research community and research participants. The Clinical Research Support Office (CRSO), offers a broad range of services, policies, direct assistance, education, advocacy, resources, and tools for members of the research community and research participants, as well as conducting original research on research best practices and fostering community engaged research. These activities and services contribute to fulfilling the mission of the Center for Clinical Translational Science (CCTS) in the areas of Translational Endeavors, Translational Workforce Development, Collaboration and Engagement, and Hub Capacity. These activities also contribute to the missions of the Hospital and the University’s Human Research Protection Program. Under the leadership of Dr. Rhonda Kost, Clinical Research Officer (CRO), the staff consists of: 1) a Clinical Research Specialist with experience in research coordination and Good Clinical Practice (GCP), expertise in FDA-regulated IND/IDE research, and experience in conducting post-approval compliance audits for quality improvement and training purposes; 2) a Community Engagement Specialist with expertise in the methods and special considerations when engaging with participants and communities in developing community-engaged research and 3) two Recruitment staff members as well as clerical support.
The Clinical Research Officer coordinates the policies, personnel, and activities of the CRSO with those of other cores and departments, including the Clinical and Translational Research Facilitation Office, and with Hospital Information Services, the Office of Regulatory Affairs, and the IRB with regard to human subject protections and ethics, quality assurance, oversight, and compliance.
The CRSO works closely with the BioInformatics Department. This collaboration is crucial as the promise of data integration, transparency, and workflow assistance integral to the IT Plan are crucial to the dissemination of commonly utilized protocol information, critical regulatory and safety information, the reduction of duplication of effort, and the removal of obstacles to the conduct of translational clinical research, all of which are critical to the success of the clinical research enterprise.
GoalsThe goals of the Clinical Research Support Office bridge four interrelated areas:
Operations, Functions and Services
- Support for and Knowledge of Regulatory Activities
- Protocol, Informed Consent, Data and Safety Monitoring Plans: The Clinical Research Support Office and the Clinical and Translational Research Facilitation Office provide complementary services to support the regulatory activities required for the successful conduct of translational and clinical research conducted at Rockefeller University Hospital (RUH). Coordination and integration of CRSO staff resources and policies affords investigators, teams, and staff support in the following areas:
- Support in achieving Patient Safety and Regulatory Management and Compliance: DSMP oversight
- Elements of Good Clinical Practice and Compliance
- Auditing and Monitoring
- Innovative assessment tools and outcome assessments to drive performance improvement and institutional best practices. The CRSO develops tools designed to measure the outcome of regulatory, educational and human protections practices. The development of the tool, its outcomes and dissemination are described in Section 5 below.
- Human Research Participant Advocacy
The role of the Research Subject Advocate is to champion the mission of the safe and ethical conduct of research through all the activities of the Hospital and Center. Research Participant Advocacy is enacted through coordination of process and policy, and informed by regulatory and ethical guidance, as well as the collection of actionable participant-centered feedback.
- Reduction And Removal Of Institutional Impediments
The third goal of the CRSO is to reduce or remove institutional impediments to clinical and translational research. The Clinical Research Support Office collaborates extensively with the Bioinformatics Department in the fulfillment of the Center Information Technology (IT) Strategic Plan, on which the Clinical Research Officer has collaborated from its conception. This collaboration has been crucial as the promise of data integration, transparency, and workflow assistance integral to the IT Plan are central to the dissemination of commonly utilized protocol information, critical regulatory and safety information, the reduction of duplication of effort, and the removal of obstacles to the conduct of translational clinical research, all of which are critical to the success of the clinical research enterprise.
- Developing and sharing tools, strategies Best Practices in Regulatory Support and Advocacy
The Rockefeller University Center for Clinical and Translational Research is committed to developing, disseminating and adopting tools and Best Practices in collaboration with the National CTSA Consortium Steering Committee. The CRSO has led a multi-institutional set of projects to develop and disseminate a Research Participant Perception Survey (RPPS) as a validated tool with which to benchmark outcomes of Clinical Research Regulatory Support, Education, Research Subject Safety and other programs across the CTSAs.
- Support for and Knowledge of Regulatory Activities