Clinical Research Associate I, Hybrid

About the role

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.

Responsibilities

• 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.
• Collections, 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).
• Affords assistance in 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.
• Affords assistance 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.
• Affords assistance with clinical trial budgets and patient research billing.
• Maintains 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.
• Might serve as one point of contact for external sponsors for select trials. Might respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Requirements

The role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

Qualifications

• 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