Cedars-Sinai Clinical Research Assoc. I - Kidney Tx in Los Angeles, California
Grow your career at Cedars-Sinai!
Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.
Join our team and use your expertise with an organization known nationally for excellence in research studies.
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.
Primary Duties and Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study.
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 contact with research participants or contact for long term follow-up research participants 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.
Schedules research participants for research visits and research procedures.
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.
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
Educational Requirements: Bachelor of Science or Bachelor of Arts Degree in biological sciences, preferred, or equivalent experience.
Licenses: ACRP/SoCRA (or equivalent) certification preferred.
Experience: Two (2) years of directly related experience, or equivalent combination of education and experienceMust demonstrate excellent communication, computer (excel, powerpoint, word), written, verbal, and organization skills.
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.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the 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, gender, 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.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the 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, gender, 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.
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