Clinical Research Coordinator I - Smidt Heart Institute (Bello Lab)
Posted on: November 16, 2022
Grow your career at Cedars-Sinai!The Smidt Heart Institute
reflects Cedars-Sinai's steadfast commitment to heart disease and
research innovation giving patients access to the highest level of
care. Year after year, thousands of people trust their hearts to
Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac
surgeons and specialized care teams treat the full spectrum of
heart disease and disorders, while our investigators continue to
advance the field with groundbreaking, life-saving research. From
genetic counseling and targeted drug therapies to an increasing
array of minimally invasive procedures, Cedars-Sinai continues to
stand at the forefront of technology, innovation and discovery
improving patient outcomes.Join our team and use your experience
with an organization known nationally for excellence in
research!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 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
- Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical
personnel, documents on Case Report Forms (CRFs) the following;
changes in patient condition, adverse events, concomitant
medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research
- Schedules and participates in monitoring and auditing
- 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.
- 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 - Smidt Heart
Institute (Bello Lab)
Department:Heart Institute Operations
Business Entity:Academic / Research
Job Specialty:Research Studies/Clinical Trials
Shift Length:8 hour shift
Keywords: CEDARS-SINAI, Altadena , Clinical Research Coordinator I - Smidt Heart Institute (Bello Lab), Healthcare , Altadena, California
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