Clinical Research Associate I, Per Diem -Surgery Chair

Cedars-Sinai; Los Angeles (CA); On-site; USD 55,000 - 85,000; Full time

Job summary

Cedars-Sinai seeks a Clinical Research Associate I to assist in coordinating noncomplex studies under supervision. Responsibilities include data collection, prescreening, CRF completion, regulatory submissions, budgeting, and sample handling, all while ensuring GCP and HIPAA compliance.

The role supports study teams with IRB activities, sponsor communications, and accurate data entry in EDCS under the direction of supervising staff.

Qualifications

• High School Diploma/GED required
• Bachelor's Degree in Science, Sociology or related field preferred
• 1 year clinical research related experience preferred

Responsibilities

• Assists in coordination/implementation of noncomplex research studies under supervision
• Collects, evaluates and abstracts clinical research data; enters data into EDCS
• Completes Case Report Forms (CRFs)
• Assists prescreening of potential participants and schedules visits
• Assists with IRB submissions and regulatory documentation
• Assists with clinical trial budgets and patient research billing
• Maintains sample preparation, shipping and study supplies
• Ensures compliance with GCP, HIPAA and FDA/local guidelines
• Acts as liaison with sponsors for select trials and meetings

Education

High School Diploma/GED - Required

Bachelor's Degree Science, Sociology or related degree - Preferred

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.

Qualifications

Education

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

Experience

• 1 year Clinical research related experience - Preferred

Education

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

Experience

• 1 year Clinical research related experience - Preferred