Kelly is hiring a Clinical Research Coordinator for one of our clients in Sacramento, CA
Location: Mercy Cancer Center, 3301 C Street, Suite 550, Sacramento, CA 95816
1 year assignment
Traveler will also FLOAT to the following locations as needed:
Mercy Cancer Center, 6511 Coyle Avenue, Suite 200, Carmichael, CA 95608
Mercy Cancer Center, 550 W Ranch View Drive, Suite 3000, Rocklin, CA 95765
Mercy Cancer Center, 9394 Big Horn Blvd, Elk Grove, CA 95758
Woodland Cancer Center, 515 Fairchild Court, Woodland, CA 95695
The Senior Clinical Research Coordinator (SCRC) 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 has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. 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 works with the MCRM to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy
In addition to managing clinical trials, the Senior Clinical Research Coordinator will provide training and mentorship, project leadership, and quality control oversight of Clinical Research Associate and Clinical Research Coordinator positions. 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 assignments.
1 Year Assignment Commitment (to start) - REQUIRED
7 years or more Research experience - Required
Must be willing to Float - Required
Bachelor Degree (or higher) - Required Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required. Current certificate of Human Subjects Protection and Good Clinical Practice training required.
Minimum 7 years of experience conducting clinical trials required; worked as primary research coordinator for at least 20 drug or device trials.
Minimum 7 years of experience interacting with patients in a healthcare setting required.
Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP 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.
Experience training staff and/or investigators on clinical trial processes and improvement techniques preferred.
Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
Experience with Microsoft Office software required.
Knowledge of medical terminology required.
Lab processing experience required.
Phlebotomy certification preferred.
IDX EMR experience - Preferred
BLS and First Aid Certification Preferred
IATA and/or Safe-T-Pak Certification for shipment of lab specimens and/or dry ice - Preferred
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