Clinical QA Coordinator — Data Quality & Compliance

Collaborative-Neuroscience-Research,-LL; Los Alamitos (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

CenExel Clinical Research in Los Alamitos, CA seeks a Quality Assurance Coordinator (Clinical Research) to help ensure data quality and participant safety in our trials. This on-site role requires adherence to ICH/GCP, FDA CFRs, and CenExel SOPs.

Responsibilities include supporting QA programs, reviewing monitoring reports and quality findings, preparing for audits, and assisting site initiation visits. Candidates have 1–2 years QA experience in clinical research and strong communication and

Qualifications

• Minimum 1-2 years relevant QA experience in the clinical research industry.
• Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines.
• Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.

Responsibilities

• 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.
• 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.

Skills

QA experience

FDA regulations

GCP

ICH guidelines

Communication skills

Detail oriented

Education

High school graduate

Bachelor's degree

Job description

CenExel Clinical Research in Los Alamitos, CA seeks a Quality Assurance Coordinator (Clinical Research) to help ensure data quality and participant safety in our trials. This on-site role requires adherence to ICH/GCP, FDA CFRs, and CenExel SOPs.

Responsibilities include supporting QA programs, reviewing monitoring reports and quality findings, preparing for audits, and assisting site initiation visits. Candidates have 1–2 years QA experience in clinical research and strong communication and