Quality Assurance Coordinator (Clinical Research)

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

Quality Assurance Coordinator (Clinical Research)

Job Category: QA/ Data Regulatory

Requisition Number: QUALI004296

• Posted : August 20, 2026
• Full-Time
• On-site

Locations

• Showing 1 location
• Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Hourly Range:

Job Summary:

Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.

Essential Responsibilities and Duties:

• Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
• Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
• Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
• Prepares for internal and external audits and FDA inspections.
• Attends site initiation visits as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• High school graduate or equivalent, Bachelors degree or equivalent preferred.
• Minimum 1-2 years relevant QA experience in the clinical research industry.
• Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills – both written and oral.
• Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
• Must be able to clearly communicate through written and verbal means with sponsors and staff.

Working Conditions

• Indoor, Office environment.
• Essential physical requirements include sitting, typing, standing, walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Qualifications

Skills

Behaviors

Motivations

Education

Experience

Licenses & Certifications

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.