Clinical Research Coordinator I - Smidt Heart Institute
Company: Cedars-Sinai
Location: Alhambra
Posted on: March 13, 2023
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Job Description:
Grow 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 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 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.--- 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.
Educational Requirements:
- Highschool Diploma/ GED required- Bachelor's degree in Science,
Sociology or related field preferred
Licenses:
- SOCRA or ACRP certification preferred
Experience:
- 1-year clinical research related experience
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 Coordinator I - Smidt Heart
Institute
Department: Heart Institute Operations
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$23.39 - $39.76
Keywords: Cedars-Sinai, Alhambra , Clinical Research Coordinator I - Smidt Heart Institute, Healthcare , Alhambra, California
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