Operational Compliance Specialist

Care Access

86d

About The Position

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. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

Requirements

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• In-depth knowledge and understanding of the requirements and organization of a clinical research site.
• Minimum of 3 years experience as a clinical research auditor or clinical research associate (CRA) / clinical trials monitor (CTM).
• Experience in training other members of staff at all levels.
• Excellent communication skills and ability to manage upwards successfully.
• Ability to work independently with minimal supervision.
• Willingness to travel regionally on a regular basis.
• Exceptional customer service skills to both internal and external stakeholders.
• Experience of working within a highly regulated environment.
• Personal skills including assertiveness, persistence, flexibility, highly organized and detail oriented.
• Experience in managing stressful situations and controversial issues.
• Expertise in reviewing, revising, and writing Standard Operating Procedures.
• Ability to manage projects/teams of significant scope and complexity.

Responsibilities

• Complete operational compliance checks on clinical trial documents at sites.
• Maintain a quality and compliance role within operations, separate from operational quality control (QC) and routine operational activities.
• Provide quality focused support to the business to achieve regulatory compliance and commercial objectives.
• Assist regional operational staff with Corrective Action and Preventive Action Plan (CAPA) definition.
• Maintain a regional CAPA owner listing and ensure quality findings and CAPAs are addressed.
• Escalate issues to management/QA.
• Support regional staff with process improvement and procedure definition.
• Facilitate and report root cause analysis to aid CAPA definition and process improvement.
• Establish and maintain processes for operational compliance, including oversight of quality control (QC), CAPA, and process effectiveness.
• Identify operational quality performance measures and provide required metrics/RAG reports to management.
• Ensure operational quality, participant safety, and data integrity through review of quality reports.
• Support internal governance structures to facilitate quality, process improvement, and compliance.
• Support development and delivery of client governance/quality agreements.
• Support the QA function with client audit and regulatory inspections.
• Maintain effective relationships internally and externally for efficient service delivery.
• Comply with company quality framework, regulatory legislation, guidelines, and international standards.
• Provide training on functional GCP and other compliance and quality related topics.
• Safeguard confidentiality of staff, participant, and sponsor matters.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level