Senior Clinical Quality Assurance Specialist
6 days ago
This is a full-time contract role offering 30–40 hours per week of consistent work. The contractor will act as a core member of the Quality Assurance function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.
Key Responsibilities:
- Serve as the primary Quality Assurance resource for clinical study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
- Provide Quality Assurance expertise during study calls, including: Protocol deviation meetings Risk-based quality management discussions Study operations and trial oversight meetings Write, review, update, and format standard operating procedures (SOPs) and other quality documentation Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management Address QA-related questions from study teams in real time, providing clear and actionable guidance Support inspection readiness and contribute to continuous improvement of QA systems and processes Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation
Required Skills and Qualifications:
- Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred)
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP Prior experience supporting clinical study teams in a QA capacity Hands-on experience with Veeva QMS Proficient in MS Office (Excel, PowerPoint, Word) Skilled in technical writing, SOP drafting, and document formatting Excellent communication and interpersonal skills Strong organizational skills with the ability to work independently Availability: Must be available during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support
Benefits:
This contract opportunity offers a stable and secure working environment with opportunities for professional growth and development.
Others:
The ideal candidate will bring strong experience with Veeva QMS, be highly tech-savvy, and able to support clinical operations teams in a fast-paced, remote environment.
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