Clinical Research Associate 2 - VCC - VICTR **REMOTE AVAILABLE**
This is a full-time/exempt term position lasting six months to one year.
This position is responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, conduct of research protocols, and data management functions, such that the clinical research is maintained and the integrity and quality of the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure, and research protocols.
DATA MONITORING (INTERMEDIATE)
- Perform remote and in certain cases on-site monitoring responsibilities and assessment of site performance. Ensure accuracy, validity and completeness of data collected. Query research team to clarify, reconcile and complete data issues. Ensure patient safety is maintained and informed consent procedures are carried out. Provide training and update investigative site team of any changes in study conduct and documentation requirements. Review clinical data, source documentation, CRF, and investigative site regulatory files, ensuring continued acceptability of the investigator, clinical site team and facility. Contribute to the expeditious completion of study procedures and data collection. Build and maintain relationships between multi-sites and VUMC.
REPORTING & DOCUMENTATION (INTERMEDIATE)
Fully document trial related monitoring, including clinical study progress. Ensure site IRB approval is current and all IRB documentation is in order. Ensure that all AEs are reported within the required reporting timelines, documented as appropriate, and consistent with all data collected and with the information in the source documents. Promptly communicate relevant status information and issues to appropriate stakeholders. Write and distribute monitoring visit reports and any supplemental documents/reports to all sites for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to investigators and their teams. Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
QUALITY ASSURANCE (INTERMEDIATE)
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Review case report forms and query generation and resolution against established monitoring plan guidelines. Act as a liaison with vendors such as central laboratories as required to ensure protocol adherence.
PROJECT ADMINISTRATION (INTERMEDIATE)
- Assist in recruitment and review of investigators, collecting investigator and site management documentation. Update, track and maintain study-specific trial management tools and systems. Ensure investigational product accountability accuracy, oversee investigational product inventory, and generate and track drug shipments and supplies as needed. Attend investigator meetings, project team meetings and teleconferences. Provide timely study updates as needed to all applicable site personnel. Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties. Act as preceptor for clinical trials staff.
About the Department:
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt's virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center's Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/ .
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