Company: USA WINZONS
Job Type: Full-Time | Remote/Hybrid/On-site
Location: United States (Flexible)
About the Role:
USA WINZONS is actively seeking a detail-driven and experienced Clinical QA Specialist to ensure our clinical research and development processes align with regulatory standards and quality assurance best practices. You will play a pivotal role in maintaining GCP (Good Clinical Practice) compliance, supporting audit readiness, and enhancing quality across clinical trials.
Key Responsibilities:
- Oversee QA activities for clinical trials, including documentation review, compliance monitoring, and CAPA tracking
- Conduct internal and external GCP audits (site, vendor, document, and process-based)
- Support clinical teams by reviewing protocols, SOPs, case report forms (CRFs), and other study-related documents
- Collaborate with clinical operations, regulatory, and data management teams to ensure audit-readiness
- Maintain inspection readiness documentation and support regulatory inspections (FDA, EMA, etc.)
- Identify and mitigate quality risks across studies and clinical vendors
- Contribute to training on GCP and quality-related procedures
Required Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
- Minimum 3 years of clinical QA or clinical research experience
- Strong understanding of ICH-GCP guidelines and regulatory requirements (FDA, EMA, etc.)
- Experience conducting GCP audits and supporting regulatory inspections
- Excellent communication, organization, and problem-solving skills
- Ability to work independently and manage multiple priorities
Preferred Qualifications:
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Experience in oncology, rare diseases, or early-phase clinical trials
- Familiarity with electronic systems (eTMF, CTMS, QMS)
What We Offer:
- Competitive salary with performance-based incentives
- Flexible work options (remote/hybrid)
- Health and wellness benefits
- Collaborative work environment with growth opportunities
How to Apply:
Submit your updated resume and cover letter to careers@usawinzons.com or apply directly via our career page.