Clinical Research Coordinator I - Phase 1 - Cancer Clinical Trials Office
Posted on: November 16, 2022
At Cedars-Sinai, we're motivated by a collective spirit of
innovation and the challenge to continuously improve. Above all, we
share a real dedication for helping others. Day after day, from
department to department, our people give their all to create a
community unlike any other. This is just one of the many reasons
U.S. News & World Report has named us one of America's Best
Hospitals-and now we invite you to join us and make a difference
every single day in service of this outstanding work - excellence
and innovation in patient care, research, and community service.
From working with a team of committed professionals to using
state-of-the-art facilities, you'll have great resources to do
something incredible-for yourself, and for others!Cedars-Sinai
Cancer is committed to pursuing pioneering research into disease
mechanism, diagnostic innovations and new technologies and
resources. Through our historic achievements, growing research
enterprise, and serving one of the most diverse regions in the
world, our physicians and scientists are uniquely positioned to
guide the next generation of progress against the disease.Are you
looking to contribute to groundbreaking research? We look forward
to having you come and join our team!The Clinical Research
Coordinator I works independently providing study coordination,
screening of potential patients for protocol eligibility,
presenting non-medical trial concepts and details, and
participating in the informed consent process. Responsible for
accurate and timely source documents, data collection,
documentation, entry, and reporting including timely response to
sponsor queries. Responsible for compiling and reporting on each
study including information related to protocol activity, accrual
data, workload, and other research information. Presents study
information at regular research staff meetings. Ensures compliance
with all federal and local agencies including the Food and Drug
Administration (FDA) and local Institutional Review Board
(IRB).Duties and Responsibilities
- Independent study coordination including screening of potential
patients for protocol eligibility, presenting non-medical trial
concepts and details to the patients, and participating in the
informed consent process.
- Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical
personnel, documents thoroughly on Case Report Forms (CRFs) the
following; changes in patient condition, adverse events,
concomitant medication use, protocol compliance, response to study
- Maintains accurate source documents related to all research
- Schedules and participates in monitoring and auditing
- Responsible for compiling and reporting on each study including
information related to protocol activity, accrual data, workload,
and other research information; present this information at regular
research staff meetings
- Notifies direct supervisor about concerns regarding data
quality and study conduct.
- Works closely with a regulatory coordinator or directly with
the Institutional Review Board (IRB) to submit Adverse Events,
Serious Adverse Events, protocol deviations, and Safety Letters in
accordance with local and federal guidelines.
- May perform other regulatory / Institutional Review Board
duties, budgeting duties, and assisting with patient research
billing and reconciliation.
- Ensures compliance with all federal and local agencies
including the Food and Drug Administration (FDA) and local
Institutional Review Board.
- 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.
- Performs phlebotomy services according to CSMC policies and
- Verifies specimen identification, assesses appropriateness of
test orders and quality of specimen by recognizing
- High School Diploma/GED required
- Bachelor's Degree Science, Sociology or related degree
- One year of Clinical Research Related experience required
- Certification in clinical Research: SOCRA or ACRP certification
Working Title:Clinical Research Coordinator I - Phase 1 - Cancer
Clinical Trials Office
Department:SOCCI Clinical Research Office
Business Entity:Academic / Research
Job Specialty:Research Studies/Clinical Trials
Shift Length:8 hour shift
Keywords: CEDARS-SINAI, Anaheim , Clinical Research Coordinator I - Phase 1 - Cancer Clinical Trials Office, Other , Anaheim, California
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