Operational Compliance Specialist - Remote

Overview

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

In Short

• Complete operational compliance checks on clinical trial documents at sites.
• Maintain a quality and compliance role within operations.
• Provide quality focused support to achieve regulatory compliance and commercial objectives.
• Assist regional operational staff with CAPA definition.
• Maintain a regional CAPA owner listing and ensure quality findings are addressed.
• Support regional staff with process improvement and procedure definition.
• Facilitate and report root cause analysis.
• Establish and maintain processes for operational compliance.
• Oversight of quality control and process effectiveness.
• Identify operational quality performance measures and provide metrics reports to management.

Requirements

• Expert working knowledge of GCP guidelines and quality regulations.
• In-depth knowledge of clinical research site organization.
• Minimum 3 years as a clinical research auditor or CRA.
• Experience in training staff at all levels.
• Excellent communication skills.
• Ability to work independently with minimal supervision.
• Willingness to travel regionally.
• Exceptional customer service skills.
• Experience in a highly regulated environment.
• Ability to manage projects of significant scope.

Benefits

• Paid Time Off (PTO) and Company Paid Holidays.
• 100% Employer paid medical, dental, and vision insurance.
• Health Savings Account and Flexible Spending Accounts.
• Company paid Short-Term and Long-Term Disability.
• 401(k) Retirement Plan with Company Match.