Assistant Director, Clinical Research Monitoring Program

Assistant Director, Clinical Research Monitoring Program

Please apply for this role at:

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.

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:

• 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, 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 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.
• 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.

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.

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.