Clinical Research Coordinator

Scott & White has a team of forty (40) Clinical Research Coordinators, twenty (20) of whom are qualified registered nurses. All of the coordinators are certified by either the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professions (ACRP).

What is a Clinical Research Coordinator?

The federal regulations do not include references to a “Clinical Research Coordinator” and do not address this role per se. A Clinical Research Coordinator is often a member of the investigator’s staff, and may be a registered nurse or other medically trained individual, although medical training is not currently required. The role of the Clinical Research Coordinator may vary from site to site and is determined by the investigator’s needs. The Clinical Research Coordinator often organizes the study program, conducts tests and procedures required for the study, completes requisite paperwork and serves as a liaison between the site and the sponsor. The Clinical Research Coordinator works closely with the study protocol.

What are the responsibilities delegated by the Investigator to the Clinical Research Coordinator?

Under the guidance and supervision of the investigator, the duties of the Clinical Research Coordinator may include the following:

• Designing and maintaining organizational tools that will aid in the conduct of the study. The study should be conducted accurately and in compliance with Good Clinical Practice
• Assisting in training other site personnel and other medical staff in understanding and implementing the protocol
• Recruiting and screening the potential study subjects according to the protocol’s inclusion and exclusion criteria
• Obtaining proper written informed consent from each study subject prior to participation in the study and documenting the consent process
• Ensuring that the signed and dated informed consent form for each subject, with the appropriate subject identification, is filed in the medical record
• Scheduling study subjects’ visits and defining the study visit activities completely and accurately by providing appropriate documentation in the case history
• Reporting all adverse events (AEs), and serious or unexpected adverse events (SAEs) to the investigator and assisting the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as the protocol and regulations require
• Maintaining adequate and accurate case report form (CRF) for each study subject that record all observations and data obtained during the study
• Maintaining adequate source documentation (any document, or record where subject’s data are first recorded). All data noted in the CRF should be verifiable by supporting source documentation [21 CRF 312.62(b)]
• Completing the CRFs for the study accurately and completely as determined by the investigator (Note: While Study Coordinators may fill our CRFs, the ultimate responsibility for the content and accuracy of a CRF rests with the Investigator, who reviews and may be required to sign each CRF indicating that they confirm all the information contained within a CRF)
• Assigning study subject numbers and maintaining accurate and complete records of the receipt, dispensing and return of all clinical supplies-noting all discrepancies
• Maintaining records of subjects’ status in the study by using tools such as enrollment log forms
• Aiding in communicating with the sponsor representative to discuss the conduct of the study and review study data in association with or as directed by the Investigator
• Following all Scott & White policies associated with the handling of the investigational products and providing clinical care
• Assisting with preparation for site visits from the FDA and other regulatory agencies by collecting and organizing all clinical sources of subject data pertinent to the clinical trial

Other resources

• www.acrpnet.org
• www.socra.org
• Clinical Research Investigators
• Grants Administration Office (GAO)
• Research Compliance Office

Back to Top