
Clinical Research Institute Coordinator - CA
- Merced, CA
- $36.00-47.58 per hour
- Permanent
- Full-time
- 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.
- 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)