Assistant Director, Clinical Research Monitoring Program

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Assistant Director, Clinical Research Monitoring Program, provides strategic leadership and oversight of oncology clinical trial monitoring activities across the Fred Hutch, University of Washington, and Seattle Children's Cancer Consortium ("Cancer Consortium"). This role is responsible for ensuring the integrity of clinical trial data and the protection of study participants by overseeing data and safety monitoring, managing quality investigations, and leading the development of Corrective and Preventive Action (CAPA) plans. The Assistant Director ensures compliance with regulatory requirements, institutional policies, and Good Clinical Practice (GCP) standards. Key responsibilities include managing monitors and support staff, developing and implementing monitoring plans, and fostering collaboration with cross-functional teams. A central focus of the role is the creation and tracking of performance metrics to drive continuous improvement and maintain high-quality clinical research operations. The Assistant Director reports directly to the Director of Clinical Research Regulatory Affairs and Compliance within Clinical Research Support (CRS).

Monitoring Oversight: Lead and manage internal clinical monitoring activities across multiple studies and sites. Ensure timely and thorough review of monitoring visit reports, follow-up letters, and action items. Ensure adherence to applicable regulatory requirements, protocols, Standard Operating Procedures (SOPs), and policies. Collaborate to address monitoring findings and implement corrective actions. Conduct monitoring activities, as necessary.

Metrics & Performance Management: Define and maintain metrics and key performance indicators (KPIs) for monitoring, safety reviews, and CAPA activities. Generate regular dashboards and reports for leadership and stakeholders. Use metrics to proactively identify trends, risks, and opportunities for process improvement.

Risk Management: Identify potential risks and trends in monitoring data and develop mitigation strategies to proactively address challenges that may impact the progress and outcomes of clinical trials. Collaborate with stakeholders in quality-related initiatives and activities.

Continuous Improvement: Drive process optimization initiatives to enhance efficiency, productivity, and compliance within the monitoring operations function.

Leadership and Team Management: Provide leadership, guidance, and mentorship to a team of professionals, fostering a culture of excellence, collaboration, and continuous learning. Provide training and support to ensure consistent monitoring practices and adherence to protocols.

Cross-functional Collaboration: Work closely with Clinical Operations, Data Management, Regulatory Affairs, and external vendors. Provide guidance and direct support to study teams for CAPA development and tracking. Support study teams in communicating and managing complex quality issues with external sponsors.

Vendor Management: Oversee relationships with external vendors, contract research organizations (CROs), and other third-party service providers involved in monitoring operations, ensuring quality and timely delivery of services. Manage budgets and resource allocation for monitoring operations activities.

Reporting and Communication: Maintain accurate and complete monitoring documentation. Generate metrics and reports for senior leadership and other relevant stakeholders on monitoring performance and compliance.

MINIMUM QUALIFICATIONS:

Bachelor's degree required.
• Minimum of 5 years of experience in clinical research monitoring, with at least 2 years in management.
• In-depth knowledge of FDA regulations, GCP guidelines, and other relevant regulatory requirements governing clinical trials.
• Proficiency in data analytics and metric-driven performance management.
• Ability to synthesize complex data into actionable insights.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Strong leadership and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Excellent organizational, analytical, and problem-solving abilities.
• Experience in team management, mentoring, and performance evaluation.
• Exceptional written and verbal communication skills.

PREFERRED QUALIFICATIONS:

• Masters degree preferred.
• Clinical research-related certification preferred.

The annual base salary range for this position is from $139,984 to $221,249, and pay offered will be based on experience and qualifications.

This position is not eligible for H1-B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).