Senior Clinical Research Nurse Cardiology
Company: Dignity Health System Office
Posted on: May 16, 2022
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 .
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
- 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
- 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'
- 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
- 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
- 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
- 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
- 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
- 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
- Attend investigator/coordinator meetings as required by study
- 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
- Other duties as assigned.LI-DH
- Minimum 7 years of experience conducting clinical trials
required; worked as primary research nurse for at least 20 drug or
- 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
- 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
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