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

Cedars-Sinai•Los Angeles, CA

1d•$25 - $34

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 coordination and implementation tasks for noncomplex research studies. The role supports research objectives through data collection, participant prescreening and scheduling, assistance with Institutional Review Board (IRB) submissions, budget and billing tasks, and compliance with federal and local guidelines. The associate collects, evaluates, and abstracts clinical research data; enters and processes data in sponsor-provided electronic data systems; and completes Case Report Forms. The role assists with participant prescreening and scheduling research visits and procedures, prepares and ships samples, and maintains study supplies and kits. Patient contact is supervised or, for long-term follow-up patients only, may be independent. The position also supports regulatory submissions, clinical trial budgets, and patient research billing. It helps ensure compliance with study protocols, research objectives, FDA and local IRB requirements, Good Clinical Practice guidelines, and HIPAA and other applicable confidentiality requirements. For select trials, the associate may serve as a point of contact for external sponsors and respond to inquiries or attend study meetings under the direction of supervising staff.

Requirements

High school diploma or GED.
CPT phlebotomy certification license.
Able to perform moderate lifting.
Able to sit, stand, and walk for prolonged periods.
Able to read papers and online documents.
Able to operate standard office equipment.
Able to exercise the physical ability and perspective acuity needed 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

Assist supervising staff with coordination and implementation of noncomplex research studies.
Collect, evaluate, and/or abstract clinical research data; assist with designing data collection or abstraction forms as needed.
Enter and process clinical research data in sponsor-provided electronic data systems and complete Case Report Forms.
Assist with prescreening potential research participants and schedule participants for research visits and procedures.
Provide supervised patient contact or independent contact for long-term follow-up patients only.
Assist with 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, research objectives, FDA and local agency requirements, Good Clinical Practice guidelines, HIPAA, and applicable law.
For select trials, serve as a point of contact for external sponsors, respond to sponsor inquiries, and attend study activity meetings under supervising staff direction.