Cedars-Sinai Clinical Research Associate II (Cancer Institute) in Los Angeles, California
Job Posting: The Clinical Research Associate II in our Cancer Institute 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. Summary of Essential Job Duties:
•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.
•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.
Education Certifications/Licensure Experience Physical Abilities Experience:
Two years of related clinical research experience.
Bachelor’s Degree required.
Physical Demands: (e.g., lifting, standing, walking)
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.