Clinical Research Specialist

Job overview

The Clinical Research Specialist role is onsite in Irvine, CA. Compensation is $45–$46 per hour. The role supports clinical studies through start-up, conduct, and closeout, with a focus on maintaining an audit- and inspection-ready Trial Master File. The specialist organizes and reviews study documentation in electronic trial systems, identifies gaps, and coordinates resolution with cross-functional partners. This work supports compliant study execution, audit readiness, and improvements in documentation quality and operational efficiency.

What you'll do

• Support study start-up, including site readiness tracking and coordination of Site Qualification Visits and Site Initiation Visits
• assist with study conduct and closeout
• maintain study documentation in eTMF and CTMS
• review essential TMF documents for completeness, accuracy, and compliance
• perform quality checks for audit readiness
• investigate missing records and compliance gaps
• partner with data management, clinical operations, and field teams on data review and issue resolution
• recommend process improvements
• maintain Good Documentation Practices.

What we're looking for

Skills & competencies

clinical research specialist

kaygen

irvine ca

clinical studies

trial master file

etmf

ctms

good clinical practice

audit readiness

documentation quality

$45-$46/hour

Work arrangement

• Weekend coverage required

Why this role

The posting names GCP, GDP, company SOPs, and regulatory audits including FDA, PMDA, and TUV.

About the employer

Kaygen Inc. is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.