Cedars-Sinai Clinical Research Associate II (Cancer Institute) in Los Angeles, California
Job Posting: The Samuel Oschin Comprehensive Cancer Institute is looking for a Clinical Research Associate II who will work directly with a Clinical Research Coordinators and Research Manager to coordinate and/or implement the laboratory processing requirements for the Clinical Research Laboratory. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is primarily responsible for processing research laboratory specimens according to protocol specifications, completing case report forms, and entering clinical research data. May assist with study budget and patient research billing. 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 Coordinators and Research Manager to coordinate/implement laboratory specimen processing for the 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.
•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.
•Responsible for sample preparation and shipping for sponsored research studies and Investigator Initiated Trials
•Responsible for 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. This includes the development of IIT laboratory manuals.
•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.
Education Certifications/Licensure Experience Physical Abilities Experience:
Two years of clinical research experience and understanding of general research objectives.
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.