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CommonSpirit Health · 11 hours ago

Clinical Research Institute Coordinator - CA

Santa Maria, CA

Full-time

Onsite

Mid Level

$36/hr - $48.69/hr

3+ years exp

CommonSpirit Health is one of the nation’s largest nonprofit Catholic healthcare organizations, dedicated to building a healthier future for all through its integrated health services. The Clinical Research Coordinator (CRC) will support the planning, implementation, and coordination of clinical trials and research projects, ensuring compliance with regulations and maintaining high standards of service.

Health CareMedicalNon Profit

Responsibilities

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

Qualification

Clinical trial coordinationElectronic data capture softwareClinical Trial Management SystemsCertified Clinical Research ProfessionalCertified Clinical Research CoordinatorCertified Phlebotomy TechnicianPatient interactionData reportingAdverse event reporting

Required

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 Research Coordinator SCRA (CCRC-SCRA) within 12 - months or

Certified Phlebotomy Technician (ANCC)

Company

CommonSpirit Health

Glassdoor3.6

Common Spirit Health is a healthcare organization that provides research programs, home health programs, and virtual care services. It is a sub-organization of CommonSpirit Health.

Founded in 2019

Chicago, Illinois, USA

10001+ employees