Specialist, Quality Assurance
New
C
Care AccessClinical Research
Remote within the United StatesFull-TimeMiddle
Salary70,000 - 90,000 USD per year
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Job Details
- Experience
- 2 years of experience in Quality Assurance; 4 years of experience in Clinical Research working in a compliance or GCP relevant role
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor’s degree.
- Minimum 2 years of experience in Quality Assurance.
- Minimum 4 years of experience in Clinical Research working in a compliance or GCP relevant role.
- Excellent knowledge of medical and research terminology.
- Working knowledge of federal regulations, GCP, 21 CFR Part 11/Part 312, and ICH GCP E6 (R3).
- Strong organizational skills and ability to manage competing priorities.
- Proficiency with clinical trials databases, IVR systems, electronic data capture, MS Word, and Excel.
- Ability to work independently with minimal supervision.
- Ability to travel up to 35%, including potential international travel.
- Strong communication skills and ability to work effectively with diverse teams.
Responsibilities
- Ensure patient safety and data integrity at clinical research sites through regular quality assurance reviews.
- Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify compliance with GCP standards.
- Execute the yearly corporate audit plan, track quality audits, and prepare outcome reports for management.
- Partner with research staff and PIs to resolve compliance issues and develop, track, and monitor CAPA plans.
- Coordinate and provide support for on-site audits and inspections conducted by external providers and regulatory agencies.
- Maintain internal quality systems, compliance trackers, and operational programs.
- Draft and maintain quality assurance Standard Operating Procedures (SOPs) to align with evolving regulations.
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