Clinical Research Coordinator

Overview

The Clinical Research Coordinator (CRC) works with the CommonSpirit Health Research Institute Research Operations Market Research Manager (MRM), 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. Under the direction of the MRM and/or Senior Clinical Research Coordinator, 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. Under the direction of the MRM and/or Senior Clinical Research Coordinator, 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. This is a non-exempt position that may require occasional overnight travel and weekend assignments.

Responsibilities

E SSENTIAL K EY J OB R ESPONSIBILITIES

(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.

Qualifications

Minimum Qualifications

Required Education and Experience

• Required Bachelor's degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree.
• Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials. Minimum 3 years of experience interacting with patients in a healthcare setting 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 with Microsoft Office software required.
• Lab processing experience required.
• Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.

Required Licensure and Certifications

• Health services license as appropriate required.
• Eligibility to sit for the exam within one year of hire or 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.
• Phlebotomy certification preferred.

Required Minimum Knowledge, Skills,

Abilities and Training

• Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
• Knowledge of medical terminology required.
• Understanding of ethical principles, culture and values of medical research.
• Critical thinking skills, decisive judgment and the ability to work with minimal supervision.
• Oncology/Hematology experience is preferred.