Clinical Research Associate II - Lawrenson Lab
Company: Cedars-Sinai
Location: Alhambra
Posted on: May 25, 2023
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Job Description:
The Clinical Research Associate II works directly with a
Clinical Research Coordinator, Research Program Administrator, or
Research Nurse to coordinate and/or implement the study and may
serve as the point of contact for the external sponsors. This role
evaluates and abstracts research data and ensures compliance with
protocol and research objectives. Position is responsible for
completing case report forms, entering clinical research data, and
assist with regulatory submissions to the IRB. Provides limited
patient contact as needed for study and assist with study budget
and patient research billing. In addition, the CRA II may
coordinate activities, training, and education for other Clinical
Research Associates. This role will comply with all federal, local,
FDA, IRS, and HIPAA guidelines and regulations pertaining to the
study and patient care.--Primary Duties Include:Enters clinical
research data into Electronic Data Systems (EDCs) provided by the
sponsors.Provides supervised patient contact or patient contact for
long term follow-up patients only.Assists with regulatory
submissions to the Institutional Review Board (IRB) and works
closely with supervising research staff or directly with the
Institutional Review Board to submit Adverse Events, Serious
Adverse Events, and Safety Letters in accordance with local and
federal guidelines.Assists with clinical trial budgets. Assists
with patient research Billing.Schedules patients for research
visits and research procedures.Responsible for sample preparation
and shipping and maintenance of study supplies and kits.Ensures
compliance with all federal and local agencies including the Food
and Drug Administration (FDA) and local Institutional Review
Board.Maintains accurate source documents related to all research
procedures using Good Clinical Practice (GCP)
guidelines.--Maintains strict patient confidentiality according to
HIPAA regulations and applicable law. Participates in required
training and education programs.May serve as the point of contact
for external sponsors for select trial.May be involved in training
and education of other Clinical Research Associates.May coordinate
activities of other associates to ensure compliance with protocol
and overall clinical research objectives.May have percent of effort
in centralized activities such as Auditing, Standard Operating
Procedure development, etc.This staff member will be part of the
Endometriosis Research Center at Cedars-Sinai Medical Center. They
will assist with the collection of specimens and data for research,
specimen management and preparation of specimens and data for use
in an ongoing research studies.Educational Requirements:BA/BS
degreeLicenses:ACRP/SoCRA (or equivalent) certification
preferredExperience:Two (2) years of related experience or
equivalent combination of education and 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
Associate II - Lawrenson LabDepartment: Home
Dept-KilpatrickBusiness Entity: Cedars-Sinai Medical CenterJob
Category: Academic/ResearchJob Specialty: Research Studies/Clinical
TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type:
DayBase Pay:$21.26 - $36.14
Keywords: Cedars-Sinai, Alhambra , Clinical Research Associate II - Lawrenson Lab, Healthcare , Alhambra, California
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