OverviewCommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.The CommonSpirit Health Research Institute, a beacon of medical advancement, offers comprehensive clinical research services and support for various research activities. Their primary focus includes multi-site clinical trials, local and large-scale data research, partnerships with industry and academia for technology and innovation research, physician-initiated research, resident-initiated research in teaching facilities, nurse-initiated research, and health sciences student-initiated research. By providing start-to-finish research services, they play a pivotal role in advancing medical knowledge and ultimately, patient care.While you're busy impacting the healthcare industry, we'll take care of you with benefits that include:Medical/Dental/Vision, FSA, Dependent Care Spending Account, Life Insurance, Short and Long-term Disability, 401k match, Paid Time Off, Wellness Program, Tuition Reimbursement, Accidental Insurance, Critical Illness Insurance, Identity Theft Protection, Employee Assistance Program, and more!ResponsibilitiesThe Clinical Research Nurse (CRN) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM) to plan, coordinate, implement and complete clinical trials and other research projects managed by the CommonSpirit Health Research Institute. The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. S/he serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice. In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to a research protocol.The incumbent independently manages all aspects of multiple clinical trials or other research projects 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 works with the MCRM 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 an exempt position that may require occasional overnight travel and weekend assignments.
Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class.
Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of practice.
Report change in research participant condition to PI and appropriate personnel in a timely manner.
Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
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.
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.
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.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
Coordinate and participate in site initiation and other sponsor-required training for all protocols. ● 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.
#LI-CSHQualificationsRequired Licensure and Certifications
Current RN license in state of employment and BLS are required.
Bachelor's required and preferrably in a science or health related field.
Minimum 3 years of experience conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trials.
Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
Minimum of 3 years of nursing experience with patients in a healthcare setting required, preferably in relevant clinical area (e.g., cardiology, oncology, neurology).
Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
Pay Range$42.69 - $61.91 /hourWe are an equal opportunity/affirmative action employer.
