Clinical Research Assoc I/CPT - Los Angeles, CA

Military Spouse Corporate Career Network•Los Angeles, CA

11d•$25 - $34

About The Position

The Clinical Research Associate I/CPT supports the coordination and implementation of noncomplex clinical research studies under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff. The role supports study objectives through tasks including data collection, participant prescreening and scheduling, assistance with Institutional Review Board (IRB) submissions, clinical trial budgets and research billing, and compliance with applicable federal and local guidelines. The position is with the Heart Institute, Cheng Lab at the Smidt Heart Institute, which conducts research and provides care across the spectrum of heart disease and disorders. The associate may have supervised patient contact or independent contact with long-term follow-up patients. The role also involves research data systems, study documentation, sample preparation and shipping, study supplies, and communication with external sponsors under supervision.

Requirements

High school diploma or GED.
CPT phlebotomy certification license.
Ability to perform moderate lifting.
Ability to sit, stand, and walk for prolonged periods.
Ability to read paper and online documents.
Ability to operate standard office equipment.
Physical ability and perceptual acuity to satisfactorily perform essential job functions.

Nice To Haves

Bachelor's degree in Science, Sociology, or a related field.
One year of clinical research experience.

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) and complete Case Report Forms (CRFs).
Assist with prescreening potential participants for clinical trials.
Schedule research participants for study visits and procedures.
Provide supervised patient contact or independent patient contact for long-term follow-up patients only.
Assist supervising staff with IRB regulatory submissions, including submissions concerning 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, clinical research objectives, and applicable federal and local agency requirements, including FDA and local IRB requirements.
Maintain research practices in accordance with 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 meetings regarding study activity under supervising staff direction.