Senior Clinical Research Nurse Cardiology

Company: Dignity Health System Office
Location: Sacramento
Posted on: May 16, 2022

Job Description:

Overview
Dignity Health is one of the nation's largest health care systems. As of June 30, 2017, Dignity Health operated more than 400 care centers, including hospitals, urgent and occupational care, imaging and surgery centers, home health, and primary care clinics in 22 states, through its network of more than 9,000 physicians and more than 60,000 employees. Headquartered in San Francisco, CA, Dignity Health is dedicated to providing compassionate, high-quality, and affordable patient-centered care with special attention to those who are poor and underserved. In its fiscal year ended June 30, 2017, Dignity Health provided $2.6 billion in charitable care and services. More information on Dignity Health is available at . -
Responsibilities
Job SummaryThe Senior Clinical Research Nurse (SCRN) 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. -In addition to managing clinical trials, the Senior Clinical Research Nurse will provide training and mentorship, project leadership, and ensures quality control compliance by Clinical Research Nurse Associate and Clinical Research Nurse and/or Clinical Research Associate and Coordinator positions. This position 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

• Contribute to the SOP review and development as delegated by the Market Clinical Research Manager
• Manages studies with Principal Investigator, Market Clinical Research Manager, Research Operations Manager, & DHRI Director to develop effective clinical research programs
• The position also requires scheduled on-call availability of varying degrees based on demands of specific studies, staff availability, and coordination of schedules.
• 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.
• Educate research team members and clinical staff; conducts ongoing training, providing updated information and guidance to Clinical Research Nurse Associate and Clinical Research Nurse and/or Clinical Research Associate and Coordinator positions.
• Periodically audit work of Clinical Research Nurse Associate and Clinical Research Nurse and/or Clinical Research Associate and Coordinator positions; provide guidance in identifying corrective actions/processes, with minimal assistance from MCRM.
• Take initiative in problem solving potential local research issues. Provide recommendations for improvements to DHRI Policies and Work Instructions.
• 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 needed--which may exceed 40 hours per week--based 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
  Qualifications
  Experience:
  • Minimum 7 years of experience conducting clinical trials required; worked as primary research nurse for at least 20 drug or device trials.
  • Minimum of 7 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 training staff and/or investigators on clinical trial processes and improvement techniques preferred. - 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.Additional Certifications preferred:
      • IATA and/or Safe-T-Pak certification for shipment lab specimens and/or dry ice -#missioncritical#LI-DH

Keywords: Dignity Health System Office, Sacramento , Senior Clinical Research Nurse Cardiology, Healthcare , Sacramento, California