Clinical QA Coordinator - Data Integrity & Compliance

Cenexelresearch; Los Alamitos (CA); On-site; USD 68,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Long-Term Disability

Short-Term Disability

Life Insurance

401(k)

Job summary

CenExel Clinical Research is seeking a Quality Assurance Coordinator to help maintain data quality and study participant safety across protocols and regulatory guidelines. The role supports QA managers, prepares for audits, and ensures compliance with ICH/GCP and CenExel SOPs in a fast-paced environment.

The position is on-site, with responsibilities spanning monitoring, documentation review, and collaboration with sponsors and staff to uphold quality standards.

Qualifications

• Minimum 1–2 years QA experience in clinical research.
• Must be self-directed with minimal supervision.
• Knowledge of FDA regulations, GCP and ICH guidelines.
• Strong organizational and communication skills.

Responsibilities

• Assists QA Manager in developing and implementing QA programs.
• Reviews monitoring visit reports and quality findings trackers.
• Performs sampling reviews to ensure protocol adherence.
• Prepares for internal and FDA inspections.
• Attends site initiation visits as needed.
• Ensures adherence to FDA CFR, ICH, GCP, and CenExel SOPs.

Skills

Self-directed

FDA regulations

GCP

ICH guidelines

Multitasking

Communication skills

Education

Bachelor's degree (preferred)

High school diploma

Job description

CenExel Clinical Research is seeking a Quality Assurance Coordinator to help maintain data quality and study participant safety across protocols and regulatory guidelines. The role supports QA managers, prepares for audits, and ensures compliance with ICH/GCP and CenExel SOPs in a fast-paced environment.

The position is on-site, with responsibilities spanning monitoring, documentation review, and collaboration with sponsors and staff to uphold quality standards.