Cedars-Sinai Clin Research Assoc I/CPT PRDM in Los Angeles, California
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. 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. Ensures compliance 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 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) including submission of 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.
Additional primary duties and responsibilities that are only performed in the specific department(s) below:
•Works directly with a radiation oncologist, medical physicist, and/or biostatistician to perform clinical research studies.
•Designs forms for data collection/abstraction. Performs data collection/abstraction.
•Processes clinical data using a range of computer applications and database systems.
•Performs data searches and other related administrative tasks.
•Assists with research protocol writing and development.
•Performs phlebotomy services according to CSMS policies and procedures. Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; take appropriate action when corrections are indicated. Identifies patients and patient samples by strict adherence to established procedures; labels samples samples accurately and completely. Reports test results to appropriate individuals and exercises professional discretion with patient information.
Educational Requirements: Bachelor's Degree Degree in Science, Sociology or related degree (preferred)
Licenses: Phlebotomy Certification CA - Required for only some positions
•1 year Clinical Research Related Experience (preferred)
•Regulatory - Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
Physical Demands: Must possess the physical ability and perceptive acuity to satisfactorily perform all direct and indirect patient care 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.