Clinical Compliance Assistant
Location: Irving, TX
Department: Beauty and Personal Care
Work Schedule : M-F; 6:30am-3:30pm AND 9:30am-6:30pm
Classification: Full-Time, Contract-to-Hire
Benefits: Full benefits package
Salary : $50-60K; DOE
Reports To: Quality Assurance Manager
Position Summary
We are seeking a detail-oriented Clinical Compliance Assistant to join our Beauty and Personal Care clinical trials team in Irving, TX. In this role, you will be responsible for reviewing and ensuring the integrity, safety, and regulatory compliance of all clinical trial data, processes, and laboratory environments. This position strictly adheres to current Good Clinical Practices (GCP) and internal Standard Operating Procedures (SOPs).
Key Responsibilities
Daily Lab & Environment Monitoring
Verify and audit patch booths before testing begins to ensure correct patch @types, testing conditions, and test article applications.
Monitor, verify, and log temperatures and humidity levels for the retain closet, test article closet, drug closet, server room, archive room, incubators, refrigerators, and freezers.
Ensure all balances are completely level and verify calibration logs.
Maintain, organize, and file all environmental and operational logs in their respective binders.
Secure and maintain keys to all restricted facility areas.
Study Compliance & Data Auditing
Conduct in-study audits and review Informed Consent Forms (ICFs) and Medical History Forms for completeness.
Review Study Administrative Notebooks and regulatory binders prior to the start of any clinical trial.
Audit data sheets, data tables, and statistical analysis results to ensure absolute accuracy.
Review serious and non-serious Adverse Events (AEs) to safeguard participant safety and data accuracy.
Witness jar fills prior to study initiation when applicable.
Inventory & Equipment Management
Inventory incoming test articles, maintain accurate accountability logs throughout the study lifecycle, and log retain samples.
Ensure facility equipment (timers, pipettes, thermometers) and standard weights are checked for monthly calibration and expiration.
Coordinate the semi-annual certification checks for facility Fume Hoods.
Documentation & Support
Maintain standard operating procedures (SOPs), standard training procedures (STPs), employee training records, CV binders for physicians, and employee acknowledgment logs.
Assist the QA Manager or QA Coordinator II in authoring new SOPs and updating existing ones.
Attend protocol and study status meetings to provide timely quality updates.
Health, Safety, & Environment (HSE)
Actively participate in the site safety program to maintain a zero-injury work environment.
Utilize necessary HSE precautions and Personal Protective Equipment (PPE) when working with chemicals, cosmetic test articles, and unknown hazards.
Monitor, enforce, and report unsafe conditions or personal injuries in compliance with company policies and government regulations.
Qualifications & Requirements
Education & Experience
Bachelor's Degree (BA/BS) from a four-year college or technical school; OR 6 months to 1 year of related experience and/or training; OR an equivalent combination of education and experience.
Certifications & Licenses (Preferred)
Current certification in Human Protections
Current certification in Good Clinical Practices (GCP)
Current certification in Bloodborne Pathogens
Core Competencies & Skills
Technical & Computer Skills: Proficiency with Microsoft Office (Word, Excel, Outlook) and Database software (FileMaker Pro).
Attention to Detail: Proven thoroughness in monitoring quality standards and reviewing complex data tables.
Organization & Planning: Excellent prioritization skills with the flexibility to manage changing clinical priorities.
Communication: Strong verbal and written communication skills; ability to collaborate ethically and professionally across teams.
For immediate consideration, please forward your updated resume.
P1
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