Clinical Research Associate I - Surgery Chair

Cedars-Sinai; Los Angeles (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Cedars-Sinai seeks a Clinical Research Associate I to support coordination and implementation of noncomplex studies. Under supervision, you will collect data, assist with prescreening participants, and help prepare CRFs, while ensuring regulatory compliance and adherence to GCP and HIPAA.

You will support IRB submissions, contribute to budgeting and billing, and manage study supplies. A High School diploma is required, with a Bachelor's preferred and about 1 year of related experience desirable.

Qualifications

• High School Diploma or GED required; bachelor's degree preferred.
• 1 year of clinical research experience preferred.
• Familiarity with GCP, HIPAA, and IRB processes is desirable.

Responsibilities

• Assist in coordination/implementation of noncomplex research studies under supervision.
• Collect and abstract clinical research data and enter into EDCs.
• Complete Case Report Forms (CRFs) and assist in prescreening participants.
• Support IRB submissions including AE/SAE safety letters per guidelines.
• Assist with research budgets and patient billing; maintain study supplies.
• Ensure compliance with FDA, IRB, HIPAA, and GCP requirements.

Skills

Data collection

IRB submissions

Data entry

GCP compliance

Education

High School Diploma/GED

Bachelor's Degree in science or related

Tools

EDC systems

Job description

Job Description

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.

• 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.

Education

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

Experience

• 1 year Clinical research related experience - preferred