Clinical Research Coordinator. I - Schwab Lab
Company: Cedars-Sinai
Location: Alhambra
Posted on: May 24, 2023
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Job Description:
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---
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
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.--- 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) guidelines.---
Maintains strict patient confidentiality according to HIPAA
regulations and applicable law.--- Participates in required
training and education programs.Education RequirementHigh school
diploma/GED requiredBachelor of Science or Bachelor of Arts Degree
Preferred--Experience and Skillset:One year of directly related
Experience-- Working Title: Clinical Research Coordinator. I -
Schwab LabDepartment: Dept of OrthopaedicsBusiness Entity:
Cedars-Sinai Medical CenterJob Category: Academic/ResearchJob
Specialty: Research Studies/Clinical TrialsPosition Type:
Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay:$23.39 -
$39.76
Keywords: Cedars-Sinai, Alhambra , Clinical Research Coordinator. I - Schwab Lab, Healthcare , Alhambra, California
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