Clinical Research Coordinator
Company: Catholic Health Initiative
Posted on: May 3, 2021
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 www.dignityhealth.org.
Clinical Research Coordinator
The Clinical Research Coordinator (CRC) 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 independently manages all aspects
ofmultiple 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 ensures compliance of the research program and its
studies with all applicable federal and state regulations, as well
asDignity 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.
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
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
- Mission and Commitment
Conveys an image of dignity and trustworthiness. Respects the
rights, privacy and differences of others. Demonstrates advocacy
for vulnerable patient populations. Connects with resources
available to assist the poor and vulnerable to provide patient
care. Supports the rights of patients in the daily delivery of
care. Uses time effectively. Utilizes supplies appropriately and
participates in recycle and re-use programs. Follows safety
policies for self and patients
- Teamwork and Collaboration
Listens to others ideas, with willingness to be influenced 2)
Functions well in teams 3) Gives common goals priority over
individual goals 4) Relates with others in a positive manner so
that maximum job results are produced. 5) Effectively uses verbal
and legible written communication skills with others. This includes
being able to read, write, speak and understand English.
- Customer / Patient Focus
Performs in a manner that enhances customer service 2)
Demonstrates the attitude that quality can always be improved 3)
Explores alternatives for doing things better.
- Standards of Conduct
Maintains patient privacy and confidentiality 2) Consistently
follows regulatory, The Joint Commission, and hospital policy
requirements relating to the release or access of protected health
information 3) Performs duties in compliance with applicable
hospital and HR policies and procedures, such as dress code and
time and attendance
- Compliance Program
Demonstrates adherence to the Standards of Conduct 2)
Independently maintains required tests, licenses, certifications,
competencies, employee health (TB screening, fit testing, etc.) and
other job-related qualifications 3) Fulfills compliance educational
requirements as directed by the Compliance Department or department
- Environment of Care
- Maintains and adheres to Hospital policy and procedures as it
relates to: 1) General safety 2) Fire safety 3) Hazardous materials
4) Patient safety 5) Infection control 6) Security management 7)
Emergency preparedness 8) Equipment management 9) Utility systems
and radiation safety
Incumbents in this position shall comply with all applicable
laws and rules including the Dignity Health Standards of Conduct
and Dignity Health policies and procedures that apply to his/her
job responsibilities, seek guidance when in doubt, promptly report
any potential or suspected violation of Dignity Health Standards of
Conduct, Dignity Health policy or procedure or applicable
laws/regulations and when requested, assist Dignity Health
personnel in investigating all allegations of violation. When
called upon, the incumbent shall assist in risk evaluation and work
collaboratively with facility/entity leaders to implement, monitor
and mitigate risk corrective pans outlined by the Compliance
- Take responsibility for his/her own actions.
- Know and comply with applicable laws and rules, including
applicable Federal health care program requirements, the Dignity
Health Standard of Conducts and Dignity Health policies and
procedures as they apply to his/her particular job
- Seek guidance as provided in the Dignity Health Standard of
Conduct and/or policies when in doubt about his/her
- Refrain from involvement in illegal, unethical or otherwise
- Promptly report any potential or suspected violation of Dignity
Health Standard of Conduct, Dignity Health policy or applicable
laws or regulations
- As requested, assist Dignity Health personnel and authorized
outside personnel in investigating all allegations of
- Meet training requirements within designated timelines
- Understand and accept consequences for failure to comply with
Dignity Health Standards of Conduct
- Minimum 3 years of experience conducting clinical trials
required; worked as primary research coordinator for at least 5
drug or device trials.
- Minimum 3 years of experience interacting with patients in a
healthcare setting required.
- 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.
- Knowledge of medical terminology required.
- Lab processing experience required.
- Phlebotomy certification preferred.
- Bachelor's degree in a science or health-related field or a
combination of education and/or additional job related experience
in lieu of the degree, 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.
- Health services license as appropriate required.
- Understanding of ethical principles, culture and values of
- 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 education to patients, families, and
other staff regarding clinical and patient care issues, 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.
- 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.
Essential Duties & Responsibilities:
- 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.
- With appropriate training/credentialing, may perform blood
draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required
by research protocols.
- 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
- Complete CRC 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.
- 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.
Keywords: Catholic Health Initiative, Oxnard , Clinical Research Coordinator, Other , Oxnard, California
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