The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This position is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignmentsREQUIREMENTS
- Note: This need requires a California RN license
- 1 Year Assignment Commitment (to start) - REQUIRED
- 3+ years or more Research experience - Required
- Hospital experience/Interaction with patients in a healthcare setting - Required
- Blind and Non-blind study experience - Required
- BSN (or higher) - Preferred
- Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) - Required
- Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP (Office for Human Research Protections) and GCP (Good Clinical Practice) requirements - Required.
- Experience in implementation of research protocols and clinical trials processes - Required.
- Experience in preparing and maintaining regulatory documents and other IRB-related study documentation - Required.
- Knowledge of medical terminology - Required.
- Lab processing experience - Required.
- Phlebotomy experience - Preferred
- IDX EMR experience - Preferred
- BLS (AHA)
STATE LICENSE REQUIREMENTS