Independent Contractor-Clinical Trials Quality & Compliance Manager

Clinical Trials Quality & Compliance Manager

At CVAUSA, quality and compliance aren't just requirementsthey're the foundation of trust. As we grow a national network of cardiovascular clinical trials, we need a leader who can ensure every site is ready, every process is sound, and every team member is empowered to excel.

The Role

As the Clinical Trials Quality & Compliance Manager, you will lead the oversight of regulatory compliance, training, and quality systems across all CVAUSA research practices. You'll be the partner sites rely on for clarity and guidance, the trainer who brings standards to life, and the auditor who ensures readiness for sponsor, IRB, or regulatory inspections.

This isn't just about maintaining complianceit's about building a culture of audit readiness, quality, and accountability across a growing research enterprise.

What You'll Do

• Drive audit readiness. Ensure every site is prepared for sponsor, CRO, or regulatory inspections by building systems that make compliance second nature.
• Conduct oversight. Lead annual routine audits and for-cause audits, providing clear findings and guiding sites toward corrective action and continuous improvement.
• Lead regulatory processes. Oversee IRB submissions, regulatory document management, and adherence to ICH-GCP, FDA, and sponsor requirements.
• Design and deliver training. Develop and administer onboarding and ongoing training programs for investigators, coordinators, and site staff that reinforce compliance and protocol adherence.
• Establish startup processes. Build and standardize workflows for new sites to ensure efficient, compliant, and high-quality study activation.
• Embed quality systems. Develop and monitor processes for accurate data collection, entry, and protocol compliance, ensuring integrity across trials.
• Support and mentor. Serve as a trusted resource for research teamsproviding training, guidance, and coaching to help sites succeed in compliance and quality.

What We're Looking For

Ideal Experience

Why CVAUSA

At CVAUSA, this role is more than oversightit's leadership. As the Clinical Trials Quality & Compliance Manager, you will set the tone for regulatory and quality excellence across our research enterprise. You'll protect patients, support sites, and ensure every trial we conduct is built on integrity and trust.

This isn't just compliance. This is building a culture of readiness, trust, and qualitydesigned, built, and led by you.