Clinical Research Associate I, Hybrid

CEDARS-SINAI; Beverly Hills (CA); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Cedars-Sinai in Los Angeles, CA is seeking a Clinical Research Associate I to support coordination of noncomplex studies under supervision. The role involves data collection, screening, scheduling participants, and assisting with regulatory submissions.

Responsibilities include collecting data, completing CRFs, assisting with IRB activities, budgeting, and ensuring compliance with GCP, HIPAA, FDA guidelines. Hybrid work with 4 on-site days per week; commute to LA required.

Qualifications

• 1 year of clinical research experience preferred.
• Experience with data collection and entry into EDC systems.
• Familiarity with IRB submissions and regulatory documentation.
• Understanding of HIPAA and GCP guidelines.

Responsibilities

• Support coordination and implementation of noncomplex studies.
• Collect and abstract clinical data; assist with CRFs.
• Assist with IRB submissions and safety reporting.
• Support research budgets and patient billing.
• Ensure compliance with FDA, HIPAA, and GCP guidelines.

Skills

Clinical research

Data collection

IRB submission

EDC data entry

Budget and billing

Education

High School Diploma/GED

Bachelor's Degree in Science/Sociology or related

Tools

Electronic Data Capture (EDC)

Job description

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

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