1+ months

Clinical Research Associate I/CPT (Clinical) - Full-Time - Smidt Heart Institute - Cheng Lab

Cedars-Sinai Medical Center
Los Angeles, CA 90006
As a full-time Clinical Research Associate I and Certified Phlebotomy Technician (CPT), you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. You will be responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited contact with research participants as needed for study and assists with study budget and research participant billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. + Will collect blood from study participants. + 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 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. + 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. Education required: + BA/BS degree, or equivalent combination of education & experience. License required: + Phlebotomy certification (LPT, CPT I or CPT II) within the state of California from an accredited agency is required. Experience required: + Understanding of general clinical research objectives. Clinical research experience, preferred. + Previous experience as a phlebotomist, strongly preferred. 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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Posted: 2021-03-01 Expires: 2021-04-30

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Clinical Research Associate I/CPT (Clinical) - Full-Time - Smidt Heart Institute - Cheng Lab

Cedars-Sinai Medical Center
Los Angeles, CA 90006

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