Clinical Research Associate I, Hybrid
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 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 applicable guidelines. This position follows a hybrid schedule with an expected on-site presence of four days per week. Applicants must be able to commute to the Los Angeles work location and, if hired, reside within a commutable distance. The role requires at least a high school diploma or GED; a bachelor's degree in science, sociology, or a related field and one year of clinical research-related experience are preferred. No license or certification is required.
Requirements
- High school diploma or GED (minimum).
- Ability to commute to the Los Angeles work location and reside within a commutable distance if hired.
- No license or certification is required.
Nice To Haves
- Bachelor's degree in science, sociology, or a related field.
- One year of clinical research-related experience.
Responsibilities
- Work under supervising staff to assist with coordination and implementation of noncomplex research studies.
- 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 and schedule participants for research visits and procedures.
- Provide supervised patient contact or independent patient contact for long-term follow-up patients only.
- Assist supervising staff with Institutional Review Board (IRB) regulatory submissions, including submissions of 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, federal and local agency requirements, and 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
