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Cedars‑Sinai IBD Institute is an international leader in the science and treatment of IBD. The IBD Institute has brought together the largest community of medical and scientific leaders to research the biology of IBD and discover intervention and prevention strategies. Our experts aim to provide enduring, precision treatment to patients around the world.

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.

Department-Specific Duties and Responsibilities:

• Understanding and implementing research protocol requirements within current IRB/HIPAA regulatory guidelines to obtain specimens in hospital environments, including during surgeries and endoscopies.
• Communicating effectively with research participants, clinicians, and investigators from diverse backgrounds to ensure proper specimen collection and handling.
• Assisting with prescreening of potential research participants for eligibility in various research projects.
• Collecting specimens both on-site and at designated off-site locations, as required by research protocols.
• Performing laboratory procedures to prepare samples for downstream experiments, storage, or shipment, including DNA extraction and quantification from saliva and cell pellets.
• Entering and maintaining accurate patient and study data in databases (e.g., LabVantage, RedCap, Excel) to support study tracking and sample banking.
• Facilitating laboratory maintenance and coordinating with other lab personnel to ensure compliance with safety and operational standards.
• Participating in research-related meetings and conference calls to support project planning and coordination.
• Utilizing standard office software (Word, Excel) and equipment for documentation and communication.
• Completing on-site training with experienced clinical research associates as part of role development.

Education:

• High School Diploma/GED, is required. Bachelor's degree preferred.

Licenses and Certifications:

• Valid CA driver's license is required.

Experience and Skills:

• One (1) year of clinical research related experience is preferred.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
• Computer skills, including Word and Excel, and ability to use standard office equipment is required.