Quality Assurance Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the quality and compliance of clinical operations at both traditional trial sites and decentralized trials.

• Ensure patient safety and data integrity through consistent quality assurance evaluations.

• Interpret and apply established QA procedures.

• Examine study-specific regulatory binders and clinical documentation for adherence to GCP standards.

• Implement the annual corporate audit strategy.

• Monitor quality assurance audits and associated activities.

• Create comprehensive audit outcome reports for management review.

• Collaborate with research personnel and Principal Investigators to address compliance concerns.

• Develop, track, and oversee Corrective and Preventive Action (CAPA) initiatives.

• Organize and facilitate on-site audits and inspections by external entities, sponsors, and regulatory bodies.

• Maintain internal quality systems, compliance tracking tools, and operational programs.

• Review, draft, and uphold quality assurance Standard Operating Procedures (SOPs).

• Provide guidance to site personnel and clinical project teams on best practices for quality and compliance.

• Stay updated on evolving GxP guidelines and interpret 21 CFR Part 11, 21 CFR Part 312, and ICH GCP E6 (R3).

• Foster a culture of inspection readiness and ongoing improvement.

• Design and present training on quality and improvement initiatives.

• Assist in the completion of Requests for Proposals (RFPs) and Requests for Information (RFIs).

• Engage with digital technologies.

• Provide quality support and consultation for AI-related projects.

• Aid in Quality Management System (QMS) administration, data accuracy, and GxP/non-GxP quality initiatives.

⛳️ Requirements

• Strong understanding of medical and research terminology.

• Comprehensive knowledge of federal regulations and good clinical practices (GCP).

• Exceptional attention to detail.

• Ability to effectively communicate and collaborate with a diverse team of professionals.

• Strong organizational abilities, including skills in prioritizing, delegating, directing, supporting, and evaluating the work of others.

• Excellent verbal and written communication skills.

• Proficient computer skills, including experience with clinical trials databases, IVR systems, electronic data capture, MS Word, and Excel.

• Capacity to manage tasks with competing priorities.

• Proven decision-making capabilities.

• A genuine curiosity and passion for learning and innovation.

• Ability to communicate potential risks and complete assigned tasks.

• Maintain a positive attitude under pressure.

• High levels of self-motivation and energy.

• Capability to work independently in a fast-paced environment with minimal supervision.

• Client service-oriented mindset.

• Experience supporting multiple sites and identifying operational gaps.

• Familiarity with internal and external audits, FDA regulations, GCP, and SOPs.

• Bachelor’s degree required.

• Minimum of 2 years in Quality Assurance.

• At least 4 years of experience in Clinical Research in a compliance or GCP-related role.

• Willingness to travel, including potential international assignments.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and company-paid holidays.

• Employer covers 100% of medical, dental, and vision insurance options.

• Health Savings Account and Flexible Spending Accounts available.

• Bi-weekly employer contributions to HSA.

• Company-paid Short-Term and Long-Term Disability benefits.

• 401(k) Retirement Plan with company matching.