Principal Investigator, Dr. Gil Melmed, is seeking a Clinical Research Associate I to join the team!

Cedars-Sinai is home to some of the most advanced biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for fostering invention and teamwork.

Are you ready to be a part of breakthrough research?

Dr. Gil Melmed's clinical research team is searching for a highly motivated Clinical Research Coordinator II/CPT to be a part of an exciting opportunity within the Inflammatory Bowel and Immunobiology Research Institute (IBIRI) at Cedars-Sinai. IBIRI is a multidisciplinary basic, translational, and clinical research program devoted to Inflammatory Bowel Diseases.

The research of Gil Melmed, MD, focuses on clinical outcomes research in inflammatory bowel disease. Specifically, he is interested in improving health outcomes, health-related quality of life, and quality of care. His research includes the role of vaccination in preventing infection, IBD disease phenotype and classification, and outcomes after surgery. Dr. Melmed oversees clinical trials of novel agents for Crohn's disease and ulcerative colitis.

We are seeking a Clinical Research Associate I (CRAI) who will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for the study and assisting with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations of the study and patient care.

Primary Duties & Responsibilities:

• 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 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 Responsibilities:

• Other tasks may include screening potential patients for protocol eligibility, assisting with scheduling, presenting non-medical trial concepts and details, and participating in the informed consent process.
• Responsible for coordination of the program’s teleconferences, meeting logistics, travel arrangements, and maintaining the Investigator’s calendar.
• In conjunction with the study team, may plan and coordinate strategies for increasing project patient enrollment, improving efficiency, and participating in weekly team huddles.
• May prepare data spreadsheets for investigator and/or department.
• May assist with grant proposals, publication preparation, and presentations.
• May need to travel for learning sessions/investigator meetings.
• Participates in required training and education programs.
• Other duties and responsibilities as assigned or required.

Education:

• High School Diploma required. Bachelor's degree preferred in Science, Sociology, or related field.

Experience and Skills:

• No experience is required. One (1) year of clinical research experience is preferred.
• Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.