Clinical Research Assoc I/CPT - Los Angeles, CA
About The Position
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 with the coordination and implementation of noncomplex research studies. The role supports research objectives through tasks such as clinical data collection, participant prescreening and scheduling, assistance with IRB submissions, budget and billing support, and compliance with federal and local guidelines. The position is with the Smidt Heart Institute, Cheng Lab at Cedars-Sinai. The institute provides specialized heart care and conducts research intended to advance the field and improve patient outcomes.
Requirements
- High school diploma or GED required.
- Phlebotomy Certification license required.
Nice To Haves
- Bachelor's degree in Science, Sociology, or a related degree preferred.
- One year of clinical research experience preferred.
Responsibilities
- Collect, evaluate, and/or abstract clinical research data; may assist in designing data collection or abstraction forms.
- Enter and process clinical research data in sponsor-provided Electronic Data Systems (EDCs).
- Complete Case Report Forms (CRFs).
- Assist with prescreening potential research participants for clinical trials.
- Schedule research participants for research visits and procedures.
- Provide supervised patient contact or independent contact for long-term follow-up patients only.
- Assist supervising staff with Institutional Review Board (IRB) regulatory submissions, including Adverse Events, Serious Adverse Events, and Safety Letters, in accordance with local and federal guidelines.
- Assist with clinical trial budgets and patient research billing.
- Prepare and ship samples and maintain study supplies and kits.
- Ensure compliance with study protocols and clinical research objectives.
- Ensure compliance with federal and local agencies, including the FDA and local IRB; maintain research practices using Good Clinical Practice (GCP) guidelines.
- Maintain patient confidentiality in accordance with HIPAA regulations and applicable law.
- May serve as a point of contact for external sponsors on select trials, respond to sponsor inquiries, and attend study-activity meetings under supervising staff direction.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
