Clinical Research Institute Coordinator - CA

Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation’s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.

The Clinical Research Coordinator (CRC) works with the Principal Investigators, co- and sub-investigators,  Senior Clinical Research Coordinator, clinical and ancillary departments, IRBs, and industry or government sponsors of research to support the planning, implementation and coordination of clinical trials and other research projects managed by the CommonSpirit Health Research Institute. Duties may vary depending on the size and complexity of each study.

This role assists with clinical trial or other research project coordination duties 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 helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as CommonSpirit Health policy. This position is responsible for maintaining quality standards for responsive service and professional documentation in compliance with CommonSpirit Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of CommonSpirit Health. 

Responsibilities and Essential Functions: 

• Coordinate and participate in site initiation and other sponsor-required training for all protocols.
• Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
• Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
• Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
• Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
• Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
• Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.
• Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
• Work with CSHRI billing staff to ensure clinical trials are performed in accordance with CommonSpirit Health requirements; complete Research Encounter Forms for all participant visits.

Required Education and Experience

• Bachelors in a science or related field. A combination of education and/or additional job-related experience in lieu of the degree.
• 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
• 3 years of experience interacting with patients in a healthcare setting
• Experience using electronic data capture software and Clinical Trial Management Systems
• Certified Clinical Research Professional (CCRP), within 12 - months or
• Certified Clinical Research Coordinator ACRP (CCRC-ACRP) within 12 - months or
• Certified Clinical Rearch Coordinator SCRA (CCRC-SCRA) within 12 - months or
• Certified Phlebotomy Technician (ANCC)