Clinical Research Associate I, Per Diem -Surgery Chair

Cedars-Sinai Medical Center•Los Angeles, CA

12d

About The Position

The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support coordination and implementation of noncomplex research studies. The role supports study objectives through data collection, participant prescreening and scheduling, assistance with IRB submissions, budget and billing tasks, and compliance with federal and local guidelines. The associate collects, evaluates, and/or abstracts clinical research data; may help design data collection or abstraction forms; 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. Patient contact is supervised, except that independent contact may be provided for long-term follow-up patients. The associate assists supervising staff with IRB regulatory submissions, including Adverse Events, Serious Adverse Events, and Safety Letters. Responsibilities also include assisting with clinical trial budgets and patient research billing; preparing and shipping samples; maintaining study supplies and kits; and ensuring protocol compliance and achievement of research objectives. The role follows FDA and local Institutional Review Board requirements, Good Clinical Practice guidelines, and HIPAA confidentiality requirements. For select trials, the associate may serve as a contact for external sponsors, respond to sponsor inquiries, and attend study activity meetings under supervision.

Requirements

High School Diploma or GED required.

Nice To Haves

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

Responsibilities

Collect, evaluate, and/or abstract clinical research data.
Assist with designing forms for data collection or abstraction.
Enter and process clinical research data in sponsor-provided Electronic Data Systems and complete Case Report Forms.
Assist with prescreening potential research participants.
Schedule research participants for study visits and procedures.
Provide supervised patient contact or independent contact for long-term follow-up patients only.
Assist supervising staff with IRB submissions, including submissions of Adverse Events, Serious Adverse Events, and Safety Letters.
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, and applicable federal and local requirements.
Maintain research practices according to Good Clinical Practice guidelines and protect patient confidentiality under HIPAA and applicable law.
For select trials, serve as a contact for external sponsors, respond to sponsor inquiries, and attend meetings about study activity under the direction of supervising staff.