Clinical Research Nurse Cardiology

Company: CommonSpirit Health
Location: Sacramento
Posted on: September 24, 2022

Job Description:

Overview CommonSpirit 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. Responsibilities Job Summary: The Clinical Research Nurse (CRN) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity 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 Dignity Health policy. This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments. Essential Duties & Responsibilities: Serve as clinical nursing knowledge role model in the care of research participants. 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. In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol. Report change in research participant condition to PI and appropriate personnel in a timely manner. With minimal guidance, implement clinical trials and research projects that meet Dignity Health Research Institute (DHRI) 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 DHRI requirements. Assist Market Clinical Research Manager (MCRM), 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. 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 Dignity Health. Attend local Dignity Health IRB and appropriate clinical department meetings, as needed, for presentation of new protocols for review. Coordinate and participate in site initiation and other sponsor-required training for all protocols. Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials. 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. Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements. Obtain PI signatures on all required study documents. 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. 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. Work with DHRI billing staff to ensure clinical trials are performed in accordance with Dignity Health requirements; complete Research Encounter Forms for all participant visits. 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 Dignity Health policy. 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. Serve as liaison between participants, physician investigators, sponsors of research, IRBs, DHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions. Complete CRN activity reports accurately, and submit in a timely manner. Attend investigator/coordinator meetings as required by study sponsors. Flex work schedule as needed to accommodate participant visits, sponsor deadlines or program needs; work hours as neededwhich may exceed 40 hours per weekbased on workload and deadlines. Complete professional and clinical education annually. Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to Dignity Health's Code of Conduct. Other duties as assigned #LI-DH Mission: Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus. Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life. As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations. Qualifications Experience: Minimum 3 years of experience conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trials. 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. 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 using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred. Experience with Microsoft Office software required. Lab processing experience required. Education: Graduate of an accredited school of Nursing required; BSN preferred; OR Current RN license and Bachelor's degree, preferably in a science or health-related field, required. 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. Licensure: Current RN license in state of employment required. BLS certification required. Special Skills: Understanding of the ethical principles, culture and values of medical research. Critical thinking skills, decisive judgment and the ability to work with minimal supervision. Demonstrated ability to work independently yet collaboratively with all members of the research community including physicians/principal investigators, research team members, IRBs, hospital and clinic personnel, and sponsors of research. Demonstrated ability to perform all research coordination duties for multiple clinical trials simultaneously. Knowledge base to provide clinical education to patients, families, and other staff, including patients who may have a terminal disease. Excellent interpersonal and communication skills, both verbal and written, required. Highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects. ---Demonstrated success in identifying and bringing in new trials and growing a research site's volume. Strong attention to detail and ability to multi-task, organize and prioritize multiple projects. Ability to formulate logical and objective conclusions and make recommendations for effective solutions. #missioncritcal #LI-DH

Keywords: CommonSpirit Health, Sacramento , Clinical Research Nurse Cardiology, Healthcare , Sacramento, California