About Us

Hawthorne Health is the leading community site network, with 50+ sites across the U.S. and leveraging intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality, compliant research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients.

Traditional trial sites are often fragmented and inefficient. Hawthorne streamlines the process by making trials scalable, cost-effective, and patient-centric. By bringing research directly into communities, Hawthorne shortens timelines and helps bring better treatments to market, faster.

About the Role

The Director of Clinical Trial Operations at Hawthorne Health is responsible for overseeing and directing all aspects of clinical trial site operations across Hawthorne’s clinical research ecosystem. This leader will ensure operational excellence, regulatory compliance, and high-quality data delivery while driving innovation in patient-centered trial execution. The role serves as the key point of accountability for site performance, enrollment success, and sponsor satisfaction, while fostering collaboration across internal teams, HEROs, and external stakeholders.

Key Responsibilities:

Operational Leadership:

• Oversee day-to-day operations of all Hawthorne Health trials, including decentralized, community, and hybrid models.
• Ensure efficient trial start-up, recruitment, conduct, monitoring, and close-out activities.
• Develop and standardize operational policies, SOPs, and performance metrics to optimize quality and consistency across sites.

Compliance & Quality Oversight

• Ensure adherence to ICH/GCP guidelines, FDA regulations, company SOPs, and sponsor-specific requirements.
• Oversee regulatory submissions, IRB/IEC approvals, and site compliance documentation.
• Monitor trial performance metrics, conduct audits, and implement CAPAs to uphold quality standards.
• Safeguard patient confidentiality and maintain compliance with HIPAA/PHI regulations.

Team Leadership & Development

• Lead, mentor, and develop trial managers, project coordinators, and cross-functional operational staff.
• Build training frameworks for project-level and site-level execution to ensure consistency and readiness.
• Foster a culture of collaboration, accountability, and continuous improvement.
• Provide coaching and career development to build a strong pipeline of operational leaders.

Performance Management

• Define, track, and report KPIs related to trial operations (enrollment, data quality, protocol adherence, and timelines).
• Identify operational risks and develop proactive solutions to mitigate delays or quality concerns.
• Report operational performance to executive leadership, providing data-driven insights and recommendations.

Stakeholder Collaboration

• Act as the escalation point for site-level operational challenges.
• Partner with sponsors, CROs, investigators, vendors, and internal functions to ensure trial success.
• Represent site operations in leadership forums and cross-functional initiatives.
• Strengthen relationships with investigators, cultivating engagement and alignment with study requirements.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or related field (advanced degree preferred).
• 5+ years of progressive clinical research experience, with a strong background in site operations and management.
• Proven track record of leading high-performing teams and driving operational success in clinical trial environments.
• In-depth knowledge of GCP, ICH, FDA regulations, and decentralized/hybrid trial models.
• Excellent leadership, communication, and organizational skills with ability to manage complex, cross-functional initiatives.
• Proficiency in CTMS, EDC, and other clinical trial management technologies.
• Strong analytical and problem-solving skills, with the ability to make data-driven decisions.

Location:

100% remote. Eastern time zone work hours preferred. Up to 50% travel.

Hawthorne Health embraces remote work and provides tools and resources to ensure cohesive team collaboration. Hawthorne Health has logistics offices in CA and MA.

To find out more about Hawthorne Health, visit: https://hawthornehealth.com