CLINICAL RESEARCH COORDINATOR I - SMIDT HEART INSTITUTE
Company: Cedars-Sinai
Location: Los Angeles
Posted on: November 7, 2024
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Job Description:
Job DescriptionGrow your career at Cedars-Sinai!The Smidt Heart
Institute reflects Cedars-Sinai's steadfast dedication 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 niche 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 a
growing 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
skills 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 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).Primary Duties and Responsibilities---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 drug.---Maintains accurate
source documents related to all research procedures.---Responsible
for accurate and timely data collection, documentation, entry, and
reporting including timely response to sponsor queries.---Schedules
and participates in monitoring and auditing activities.---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) guidelines.---Maintains strict patient
confidentiality according to HIPAA regulations and applicable
law.---Participates in required training and education
programs.QualificationsEducational Requirements:
Keywords: Cedars-Sinai, Santa Barbara , CLINICAL RESEARCH COORDINATOR I - SMIDT HEART INSTITUTE, Healthcare , Los Angeles, California
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