Cedars-Sinai Clinical Research Associate II in Los Angeles, California

Requisition #: 27652
Working Title: Clinical Research Associate II
Business Entity: CSMC - Cedars-Sinai Medical Center
Cost Center # - Cost Center Name: 0879063 - Heart Institute Operations
City: Los Angeles
Job Category: Research/Research Admin
Job Specialty: Clinical Research
Position Type: Regular-F/T
Shift Length: 8hr
Hours: 8am - 4:30pm
Days: Monday - Friday
Shift Type: Day
Weekends: As Needed

Job Posting: 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, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Works with a Clinical Research Coordinator or 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) 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 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.

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

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

• 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 some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.

Educational Requirements:

BA/BS degree

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Two (2) years of directly 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.

Qualification Requirements/Preferences:

Education Certifications/Licensure Experience Physical Abilities Educational Requirements:

BA/BS degree

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Two (2) years of directly 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.

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Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.