Clinical Research Specialist I - Clinical Research Office
Location: Beverly Hills
Posted on: May 24, 2023
Grow your career at Cedars-Sinai!Cedars-Sinai offers a culture
of happiness, passion, and dedication. This is one of the many
reasons why we rank as one of the top hospitals in California and
in the nation by U.S. News & World Report.The Clinical Research
Specialist I provides clinical research expertise by participating
in the design and implementation of research projects as needed.
The incumbent is responsible for specific and assigned aspects of
research infrastructure development, coordinates projects, and
communicates status and improvement areas to leadership. The team
member in this role may implement and coordinate department-wide
initiatives such as research quality management or clinical trial
recruitment efforts, and ensures compliance with all federal and
local agencies including the Food and Drug Administration (FDA) and
local Institutional Review Board (IRB).Primary Duties and
- Coordinates research projects at an institutional or
- Communicates project status and improvement areas with
leadership in a timely manner.
- Projects may include, but are not limited to
investigator-initiated protocol development including protocol
writing, case report form development, budget development, and
coordination of departmental research committees.
- Maintains research practices using Good Clinical Practice (GCP)
- Maintains strict patient confidentiality according to HIPAA
regulations and applicable law. Participates in required training
and education programs.Department-Specific Responsibilities:
- The Clinical Research Specialist is responsible for efficient
management of the SOCCI Data Safety Monitoring Committee as well as
other major projects that are needed to support the CCTO.
- Provides project management support by coordinating meetings
and materials primarily for the Data Safety Monitoring Committee
(DSMC) meetings and secondarily to the Protocol Review and
Monitoring Committee (PRMC).
- Independently prioritizes workload and performs a comprehensive
review of all cancer related clinical research study monitoring,
audit and safety reports and responses to be reviewed by the DSMC,
within the appropriate timelines, and implements the operations of
- Incorporates knowledge of the principles of clinical trials
conduct, in order to assess the readiness of research protocol
reports and other review documents for review by the DSMC.
Identifies the need for any ad-hoc members and works with the Chair
to assign reviewers.
- Serves as the primary point of contact for DSMC inquiries and
provides technical support for investigators and staff.
- Maintains all DSMC required documentation and ensures accurate
recording of DSMC reviews into the clinical trial management system
- Attends all DSMC committee meetings, ensuring procedures are
followed and that minutes of committee meetings are taken,
reviewed, and stored in an organized manner.
- Assists in implementing modifications to the committee
charters, establishment of processes, training materials or
- Finds opportunities to better meet the National Cancer
Institute (NCI) criteria for feasibility and scientific review of
protocols and ongoing data safety and protocol monitoring.
- Ensures meeting materials (e.g., SAE reports, protocol
deviation reports, etc) are organized with the goal of enhancing
review of information by the committee and aid in decision
- Onboards and trains new DSMC members.
- Works with CCTO management to establish and optimize metric
- Regularly evaluates DSMC process for areas of inefficiency, and
works with CCTO management to propose and implement changes for
improving processes, and upon approval incorporates changes into
the SOP and Charter.
- Co-authors committee decisions on responses to investigators,
assures these are reviewed, signed by the DSMC Chair, and
communicated promptly to the investigator.
- Communicates in a timely manner with Leadership regarding
significant or time sensitive issues that arise that my hinder
processing of reviews.
- Assists in management of SOCCI Protocol Review and Management
Committee by serving as a backup when necessary.
- Assist in the management of the day-to-day operations and
system applications associated with Clinical Trial Reporting
Program (CTRP), including registering required CCTO trials in CTRP
and abstracting relevant information from protocol and CTMS for
submission to the CTRP Registration Site.
- Assists with quarterly reporting of minimum elements of patient
accrual information (for Complete and Abbreviated trials) either
via the CTRP Accrual Registration Web Site; or Accrual Batch file
- Works closely with PIs and study teams, and monitor CTMS data
entries, to assure that all applicable trials are registered on the
CTRP Registration as required by NCI policies.
- Verifies and troubleshoots protocol web summaries (Trial
Summary Report, TSR and xml file) as developed by CTRP, and
maintain the CTRP electronic protocol listing. This function
requires understanding of CTRP reports in light of submitted trial
- Performs other related duties as assigned or directed by
Leadership to meet the goals and objectives of the
CCTO.--Education: Bachelor's degree (BA or BS) is
required.Licenses/Certifications:Certification through a
professional organization such as Regulatory Affairs Professional
Society (RAPS) or The Society of Clinical Research Associates
- 3 years of related experience in a similar position is
- Prior monitoring or auditing experience in clinical research
- Strong knowledge of federal, state, and local regulations
regarding the conduct of clinical trials, the informed consent
process, and protection of human subjects.Physical Demands:Able to
perform moderate lifting. Able to sit, stand and walk for prolonged
periods of time. Able to read papers and online documents. Able to
operate standard office equipment. Able to exercise physical
ability and perspective acuity to satisfactorily perform essential
job functions. Working Title: Clinical Research Specialist I -
Clinical Research OfficeDepartment: SOCCI Clinical Research
OfficeBusiness Entity: Cedars-Sinai Medical CenterJob Category:
Academic/ResearchJob Specialty: Research Studies/Clinical
TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type:
DayBase Pay:$64,800.00 - $110,000.00
Keywords: Cedars-Sinai, Beverly Hills , Clinical Research Specialist I - Clinical Research Office, Healthcare , Beverly Hills, California
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