CRI 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.

(45%) Market/Site Research Operations:

• 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.
• Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
• With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
• 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.
• Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health.
• To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long term research studies. Actively recruit, screen and enroll participants in trials.
• Attend investigator/coordinator meetings as required by study sponsors.
• 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.
• Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.

(35%) Quality Assurance / Performance Improvement

• Implement and monitor clinical trials and research projects that meet CommonSpirit Health Research Institute (CSHRI) and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as CSHRI requirements.
• Supports MRM, PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors’ feasibility questionnaires.
• Work with CSHRI billing staff to ensure all research activity is performed in accordance with CommonSpirit Health requirements; complete Research Encounter Forms for all participant visits.

General Duties (20%)

• Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to CommonSpirit Health's Code of Conduct.
• Flex work schedule as needed to accommodate participant visits, sponsor deadlines or program needs; work hours as needed--which may exceed 40 hours per week--based on workload and deadlines.
• Attend local CommonSpirit Health IRB and appropriate clinical department meetings, as needed, for presentation of new protocols for review.
• Obtain PI signatures on all required study documents.