Clinical Research Assoc I/CPT - Heart Institute, Cheng Lab

The Department of Cardiology is committed to providing world-class care while engaging every patient with our high-caliber academic programs. Cedars-Sinai Cardiology is recognized as one of the top five programs in the nation, given our ability to combine the very best quality clinical care with leadership in cutting-edge scientific discovery, education, and training. As a result, all cardiology providers and team members are strongly dedicated to a mission of integrated clinical and research excellence. We invite you to join our team and our collective effort to continue making a positive difference for our patients and all communities affected by cardiovascular disease.

Come join Dr. Cheng’s Team!

Join our team and use your experience with an organization known nationally for excellence in research!

The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary Duties and Responsibilities

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs)
• Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Assists supervising staff 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 and patient research billing
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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
• May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Educational Requirements:

- High school diploma/GED required
- Bachelor's degree in Science, Sociology or related degree preferred

Licenses:

- CPT- Phlebotomy Certification license required (California Department of Public Health)

Experience:

1 year clinical research experience preferred

Experience with patients in various healthcare settings, good communication skills scheduling experience a plus and great organizational skills - highly preferred

Physical Demands:

- 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.