Clinical Research Associate I, Hybrid

Our take on this role

About this role

Support noncomplex research studies under supervising staff by collecting data, prescreening potential participants, and scheduling research visits. The hybrid schedule expects four days per week on-site in Los Angeles.

What could you bring from clinical work?

• Nurses and PTs: Your experience following structured care protocols and documenting outcomes could help you support compliance with study protocols.
• OTs: Documenting clinical information may provide a foundation for collecting and abstracting clinical research data.
• Social workers: If you've gathered relevant information from patients, that experience could help when assisting with prescreening potential research participants.
• SLPs: Experience coordinating appointments with patients and families could help you schedule participants for research visits and procedures.

Full job description from Cedars-Sinai

This role follows a hybrid work schedule with an expected on-site presence of 4 days per week. Applicants must be able to commute to our Los Angeles work location and, if hired, must reside within a commutable distance.

The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Responsibilities:

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Qualifications

This role follows a hybrid work schedule with an expected on-site presence of 4 days per week. Applicants must be able to commute to our Los Angeles work location and, if hired, must reside within a commutable distance.

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree. - preferred

Experience

• 1 year Clinical research related experience - preferred

Licenses and Certifications

• No license or certification required