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Cedars-Sinai · 1 month ago

Clinical Research Associate II - Women's Cancer Program - Full-Time, On-Site

8635 W 3rd St, Los Angeles, CA, 90048, US

Full-time

Onsite

Mid Level

$21.26/hr - $36.14/hr

Cedars-Sinai is seeking a Clinical Research Associate II to join their Women's Cancer Program. This role involves coordinating and implementing complex research studies, supporting data collection, regulatory submissions, and ensuring compliance with clinical research protocols.

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Comp. & Benefits

Responsibilities

Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies

Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors

Completes Case Report Forms (CRFs)

Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently

Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines

Assists with clinical trial budgets and patient billing

Responsible for sample preparation and shipping and maintenance of study supplies and kits

Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law

May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities

Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives

Participates in centralized activities such as auditing, Standard Operating Procedure development, etc

May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications

May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives

Qualification

Clinical research coordinationData collectionAbstractionRegulatory submissionsElectronic Data Systems (EDCs)Clinical Practice (GCP)TrainingEducationPatient confidentialityBudgetBilling assistance

Required

Collects, evaluates and/or abstracts clinical research data

May assist in designing forms for data collection/abstraction

Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors

Completes Case Report Forms (CRFs)

Independently prescreens potential research participants for various clinical trials

Schedules research participants for research visits and research procedures

May provide increasingly independent contact with research participants and/or conduct research participant visits independently

Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB)

May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines

Assists with clinical trial budgets and patient billing

Responsible for sample preparation and shipping and maintenance of study supplies and kits

Ensures compliance with protocol and overall clinical research objectives

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB

Maintains research practices using Good Clinical Practice (GCP) guidelines

Maintains strict patient confidentiality according to HIPAA regulations and applicable law

May serve as the primary point of contact for external sponsors for select trials

Responds to sponsor inquiries and attends meetings regarding study activities

Participates in and provides training and education to other Clinical Research Associates

May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives

Participates in centralized activities such as auditing, Standard Operating Procedure development, etc

May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications

May provide coordination of minimal number of noncomplex research studies or projects independently

May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives

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.

Founded in 1902