The Rockefeller University - Center for Clinical and Translational Science

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Clinical Research Coordinator Services

A department of six Clinical Research Coordinators (CRCs) and one data entry clerk will assist investigators in the day to day regulatory and clinical management of their protocols. The Clinical Research Coordinator (CRC) is a specialized research professional who manages the daily operations of a clinical investigation and works with and under the direction of the clinical investigator. The CRC supervises the daily activities of clinical trials, plays a critical role in the study conduct, and has a wide range of responsibilities. Paired teams of coordinators will provide cross training and coverage, thus, ensuring continuous coverage for most clinical research protocols.

The functions of the CRCs are critical to the dual missions of performing research projects under Good Clinical Practice (GCP) and teaching the K-12 Clinical Research Scholars the process of team-based clinical research under the principles of GCP. The responsibilities of the CRCs are extensive (see list below) and complement the services provided by research nurses who focus primarily on patient care.

The CRC will work with research nurses to develop a specific study conduct workflow or study management plan to ensure that all elements of the research plan are included in the scheduled outpatient visits and/or inpatient stays. In addition, the CRC will work with individuals in the Clinical and Research Support Office (CRSO) and with individuals in Biomedical Informatics to create case report forms and research databases to house study data. The process of data entry into case report forms will be supervised by the CRCs and conducted by the data entry clerk. Thus, CRCs will advance medical research conducted in The Rockefeller University Center for Clinical and Translational Research by supporting investigators in all phases of protocol implementation.

Functions of the Center for Clinical and Translational Science Department of Clinical Research Coordinators (CRCs)
Investigator Support	Guide through protocol development and submission process Assist with protocol design and implementation
Standardization of Research Procedures	Develop standard operating procedures Develop research best practices
Education	Develop and maintain an orientation and continuing education program for new CRCs. Assist investigators in the hiring, orientation, and continuing education processes for other team members supported by that research group. Support Investigator-hired CRCs through management of continuing education, access to standard operating procedures, and cross coverage from the Center-based CRC pool.
Temporary Support	Provide investigators with additional study assistance in the event of personnel turnover
Retention of CRCs	Promote retention of CRCs through cross coverage and flexible scheduling Provide opportunities for continuing education, both on-site and at regional and national meetings
Data Support	Provide data entry support to ensure that CRC's are free to focus on the more complex aspects of the daily activities of clinical trials.

Functions of Clinical Research Coordinators (CRCs)
Feasibility Evaluation	Review the research protocol while under development Review subject eligibility requirements and determining if the proposed subject population is available. Assess the ability to meet study milestones in light of other commitments Assess the resources necessary to conduct the study, including personnel, physical space, and materials (e.g., study support tools and case report forms) Gather data to assess financial feasibility of performing the study (dependent upon type of study/investigator)
Informed Consent Process	Interact with the investigator, sponsor (if appropriate) and/or IRB on informed consent wording issues Obtain informed consent Maintain all consent-related forms Review the informed consent forms for quality and completeness Coordinate the re-consent process as needed with regard to protocol amendments
Study Management	Recruit, contact and screen potential subjects for the study Schedule subject and sponsor visits and prepare for each subject visit Assure all data collection and documentation tools are prepared Assist the investigator with study subject visits Ensure that all necessary data are gathered and recorded in the appropriate source documents (e.g., patient charts) and the case report forms in the regulatory binder Review case report form entries for completeness, appropriateness and logic. Work with monitors during monitoring visits Ensure that test article accountability is completed correctly for each subject and for the overall project (if applicable) Ensure that project laboratory procedures are conducted according to standard operating procedures Reorder study supplies as necessary Manage payments to study subjects, if appropriate Complete study closeout activities at the end of the study Collaborate with the Clinical Research Support Office (CRSO) on Regulatory, Compliance and Human Subject advocacy issues, as appropriate
Other Duties	Collaborate with other departments (e.g. Nursing, Clinical Research Support Office, Pharmacy) as necessary and participate in problem solving Assist the investigator with financial aspects of the trial, including budgeting and contracts Coordinate regulatory audits
Clinical Research Coordinators who are also Nurse Practitioners	Assist with screening, enrollment, and medical evaluations Review clinical laboratory findings and make correlations with clinical events Manage reporting of adverse events Oversee clinical aspects of inpatient study periods Conduct clinical rounds regularly with team members