About Care Access
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 to 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.
To learn more about Care Access, visit www.CareAccess.com.
The Director/Senior Director Site Excellence is a senior leadership role accountable for the strategy, design, build-out, and delivery of operating models supporting specialized, non-traditional, and partner-operated clinical research sites across the United States.
This role is intentionally designed for a leader who can operate at both altitude and ground level—setting strategy, defining governance, and building scalable frameworks, while also remaining deeply hands-on in execution, problem-solving, and site engagement. The portfolio requires differentiated management outside the traditional site network due to its unique operational, regulatory, and partnership nuances.
The role demands a leader who can build processes, translate site-level realities into enterprise processes, and personally drive outcomes during periods of growth, complexity, and change.
- Strategic Leadership & Portfolio Oversight
- Own the end-to-end strategy, operating model, and performance of US-based specialized and franchise clinical research sites.
- Identify opportunities to scale, optimize, or replicate successful site and franchise models.
- Hands-On Execution & Delivery
- Serve as the primary owner for building and operationalizing processes across site startup, enrolment, performance management, quality oversight, and partner engagement.
- Engage directly with sites and partners to assess operations, diagnose issues, and drive rapid resolution.
- Lead critical initiatives personally until they are stable, scalable, and ready for delegation.
- Act as the senior escalation point for complex operational, regulatory, and partner challenges.
- Operational Excellence & Scalability
- Oversee site startup, onboarding, and integration for new specialty site models.
- Build and embed operational excellence frameworks informed by best practices from high-performing sites.
- Establish KPIs, dashboards, and review cadences to monitor performance across quality, enrolment, timelines, cost, and patient experience.
- Drive continuous improvement initiatives to enhance efficiency, scalability, and operational resilience.
- Partner & Stakeholder Leadership
- Serve as the executive owner for partner site relationships, ensuring alignment with quality standards, brand expectations, and contractual obligations.
- Lead senior-level engagement with sponsors, CROs, and internal stakeholders tied to partner and specialized sites.
- Translate protocol, sponsor, and regulatory requirements into practical, scalable guidance for site execution.
- Quality, Compliance & Risk Ownership
- Ensure all sites operate in compliance with GCP, FDA regulations, IRB requirements, and applicable state and federal laws.
- Partner with Quality, Compliance, and Legal teams to proactively identify and mitigate operational and regulatory risks.
- Oversee audit readiness, inspection outcomes, and corrective/preventive action plans across the portfolio.
- Financial & Business Accountability
- Own P&L performance for specialized and partner site operations.
- Partner with Finance to build budgets, forecasts etc.
- Identify opportunities for sustainable growth, margin improvement, and cost optimization.
- Team Leadership & Capability Building
- Build and lead a high-performing leadership team responsible for site operations and operational excellence.
- Establish role clarity, decision rights, and performance expectations across the organization.
- Coach leaders to move from reactive site support to proactive, scalable execution.
- Maintain personal ownership of critical workstreams while building long-term organizational capability.
- Demonstrated success building and scaling non-traditional, partner-led, or complex site operating models.
- Proven ability to operate as both strategist and hands-on operator in high-growth or ambiguous environments.
- Deep understanding of site-level execution: startup, enrolment, regulatory processes, sponsor engagement, and remediation.
- Strong working knowledge of FDA regulations, GCP, and clinical trial operations.
- P&L ownership experience across multi-site portfolios.
- Exceptional executive communication, influence, and change-management skills.
- Preferred:
- Experience standing up sites or operational excellence functions.
- Background in decentralized or innovative clinical trial delivery models.
- Experience operating in matrixed, global organizations.
- Bachelor’s degree required; advanced degree (MBA, MPH, MS, or similar) strongly preferred.
- 12–15+ years of progressive leadership experience in clinical research operations, site management, or healthcare services.
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
- 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
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: [email protected]
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