Clinical Research Associate I - Heart Institute jobs in United States
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Cedars-Sinai · 4 months ago

Clinical Research Associate I - Heart Institute

Cedars-Sinai is a leading healthcare organization known for its dedication to heart disease and research innovation. The Clinical Research Associate I will coordinate and implement clinical studies, ensuring compliance with research protocols and assisting with data management and regulatory submissions.

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Comp. & Benefits

Responsibilities

Provides primary support to the Research Director on his academic activities (seminars, lectures, meeting, writing, and editorial commitments). May include preparing first drafts, editing drafts, and submitting materials on his behalf
Provides other general administrative support to the Research Director, as needed
Works directly with imaging technician, ancillary support team, Investigators, nurses, nurse practitioners, and/or biostatistician to perform clinical research studies
Designs forms for data collection/abstraction. Performs data collection/abstraction
Retrieves non-controlled substance medication from and return unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study
Evaluates and abstracts clinical research data from source documents
Ensures compliance with protocol and overall clinical research objectives
Completes Case Report Forms (CRFs)
Enters clinical research data into Electronic Data Systems (EDCs) that are 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) including submission of 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 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

Qualification

Clinical Research CoordinationData Collection/AbstractionRegulatory SubmissionsElectronic Data SystemsClinical PracticePatient ConfidentialityAdministrative Support

Required

Works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study
Evaluates and abstracts research data and ensures compliance with protocol and research objectives
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
Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care
Provides primary support to the Research Director on his academic activities (seminars, lectures, meeting, writing, and editorial commitments)
May include preparing first drafts, editing drafts, and submitting materials on his behalf
Provides other general administrative support to the Research Director, as needed
Works directly with imaging technician, ancillary support team, Investigators, nurses, nurse practitioners, and/or biostatistician to perform clinical research studies
Designs forms for data collection/abstraction
Performs data collection/abstraction
Retrieves non-controlled substance medication from and return unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member
Evaluates and abstracts clinical research data from source documents
Completes Case Report Forms (CRFs)
Enters clinical research data into Electronic Data Systems (EDCs) that are 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) including submission of 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 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

Company

Cedars-Sinai

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Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Funding

Current Stage
Late Stage
Total Funding
$63.31M
Key Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M

Leadership Team

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Thomas Priselac
President/CEO
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David Wrigley
Executive Vice President Finance, CFO and Treasurer
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