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MODULE A: Clinical Research Coordinator Roles and Responsibilities

MODULE A: Clinical Research Coordinator Roles and Responsibilities. Denise K. Thwing, MAS, RN, CCRA Associate Director Project Management. Key Players. Ideal Characteristics. Scientific/medical background Interest in advancing medical needs of patients Interest in research Detail oriented

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MODULE A: Clinical Research Coordinator Roles and Responsibilities

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  1. MODULE A:Clinical Research Coordinator Roles and Responsibilities Denise K. Thwing, MAS, RN, CCRA Associate Director Project Management Version: Final 24-Mar-2010

  2. Key Players Version: Final 24-Mar-2010

  3. Ideal Characteristics • Scientific/medical background • Interest in advancing medical needs of patients • Interest in research • Detail oriented • Organizational Skills • Ability to multi-task • People skills • Communication skills • Creative and Flexible Version: Final 24-Mar-2010

  4. Roles and Responsibilities • The definition of a CRC as per the Association of Clinical Research Professionals is: “A Clinical Research Coordinator, Study Site Research Nurse or Study Site Coordinator works at a clinical research site under the direction of a principle investigator, whose research activities are conducted under Good Clinical Practice regulations. Version: Final 24-Mar-2010

  5. Roles and Responsibilities • Roles and responsibilities have not been formally described in the ICH-GCP guidelines. Their role remains vague and ill defined. • CRC responsibilities vary greatly from institution to institution. • Responsibilities depend on what is delegated by the Investigator. Version: Final 24-Mar-2010

  6. Roles and Responsibilities • Administrative Duties • Protocol feasibility for the site • Incidence and prevalence rates for major diseases • Contracts • Budgets per institution/sponsor • Assist/Complete IRB documents • Completion of required templates • Interacts regularly with PIs, IRBs, Sponsors, CRAs, Clinics, Pharmacies, Radiology Facilities, etc. • Know your hours of operation, clinic schedule, PI, sub-I availability • Maintain contact information Version: Final 24-Mar-2010

  7. Roles and Responsibilities • Maintain Documents • IRB Correspondence/ICFs • Source documents • CRFs/eCRFs • CVs, local lab certificates • Study reference manual Version: Final 24-Mar-2010

  8. Roles and Responsibilities • Coordinate/participate in Monitoring visits • Ensure all materials are prepared for review • Second QC ideal • Reserve space for CRAs/sponsors • Allow time to spend with CRAs to make corrections/reply to DCFs • Coordinate activities staff Version: Final 24-Mar-2010

  9. Roles and Responsibilities Version: Final 24-Mar-2010

  10. Roles and Responsibilities • Interactions with Subjects/families • Recruit/screen • IRB approved advertising/posters/TV/Radio • Consent • Verify all elements are present • Verify correct version • Conduct study visit procedures • Know your protocol • Verify CRF captures all data in the protocol • Drug dispensing/accountability • Retention/follow-up/study reminder appt cards/calendars Version: Final 24-Mar-2010

  11. Roles and Responsibilities Version: Final 24-Mar-2010

  12. Roles and Responsibilities • Challenges • On time patient visit schedule • Clinic space • Investigator availability • Time to record legible data, review for accuracy/ answer DCFs • Diary compliance • Lab assessments/difficult sticks • Initial and ongoing assessment lab/clinical data • Change from baseline/causes • Abnormal values/why? • Ensure patient compliance with protocol/deviations Version: Final 24-Mar-2010

  13. Roles and Responsibilities • A survey of trial subjects showed that listening, providing information and answering questions from subjects are some of the most important aspects of the role of the CRC. • In one survey where study subjects reported an excellent relationship with the CRC, more than 88% felt that the CRC positively influenced their participation in the trial. • The CRC/subject relationship positively influenced subject compliance. • J.Obstet.Gynecol Neonal Nursing:1997 May-Jun; 26 (3): 279-85 Version: Final 24-Mar-2010

  14. Roles and Responsibilities • Laboratory • Obtain/prepare samples • Know protocol samples/time points • Know refrigerator/freezer requirements • OHSA regulations • Know courier/package, country requirements and pick-up locations/times • IATA certification • www.iata.org • CLIA – Clinical Laboratory Improvement Amendments • CAP – College of American Pathologists Version: Final 24-Mar-2010

  15. Roles and Responsibilities • Personal Responsibilities • Training/stay current • GCP/ICH yearly • Attend conferences/accreditation/ACRP/SoCRA • IRB policies and procedures • www.fda.gov • Reference room: Code of Federal Regulations Version: Final 24-Mar-2010

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