Clinical Retention and Training (CRT) provides trained Clinical Research Coordinators (CRCs) to assist investigators with clinical trials.
Coordinators hired by CRT include qualified registered nurses and non-medical staff with varied undergraduate and post-graduate degrees, often in other health care fields. CRT also provides classroom education in addition to one-on-one ongoing mentoring and training for CRCs while they work in their assigned areas. CRCs are trained in all aspects of clinical trial conduct, including training on federal research regulations and research Good Clinical Practice (GCP).
Role of Clinical Research Coordinators (CRCs)
The role of the CRC varies depending on the investigator’s need and the research protocol requirements. In general, the CRC is responsible for organizing each research trial from inception to completion. The CRC works with the investigator to ensure that all required procedures are conducted and that the subsequent data is reported accurately for analysis.
Under the guidance and supervision of the investigator, the duties of the CRC may include the following:
- Designing and maintaining organizational tools that will aid in the conduct of the study.
- Assisting with training for site personnel and other staff on the study protocol
- Recruiting and screening the potential subjects according to the protocol’s inclusion and exclusion criteria
- Obtaining and managing proper written informed consent from each study subject prior to participation in the study and documenting the consent process
- 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 with reporting to the Sponsor/IRB
- Maintaining adequate and accurate case report forms (CRFs) and source documentation for each study subject that record all observations and data obtained during the study
- 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 they confirm all 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
- Aiding in communications with the sponsor to discuss the study and review study data in association with or as directed by the Investigator
- Following all Baylor Scott & White Health / Baylor Scott & White Research Institute 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
Upon eligibility, all CRCs are required to pass a national certification exam for research professionals administered by the Society of Clinical Research Associates (SoCRA).
Central TX Region: 254.771.4858
North TX Region: 214.820.2687