Senior Clinical Research Nurse Cardiovascular

  • Anywhere

Company :
Dignity Health

Location :
Sacramento, California

Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT

Apply Job :
Open Link

Description :

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.



Senior Clinical Research Nurse (Cardiology)


The 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.


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.


Occasional overnight travel to investigator meetings and to Dignity Health’s
operating regions, corporate headquarters, Dignity Health facilities and
corporate satellite offices.


This position reports directly to the Dignity Health Research Institute Market
Clinical Research Manager and will have no direct reports. This position will
provide training and functional oversight of Clinical Research Nurse Associate
and Clinical Research Nurse and/or Clinical Research Associate and Coordinator
positions. Serves as a mentor and trainer for support staff and new employees.

* 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
* 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
* 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
* 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