Fred Hutch
Assistant Director, Clinical Research Monitoring Program
Fred Hutch, Seattle, Washington, us, 98127
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.
Assistant Director, Clinical Research Monitoring Program 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.
Responsibilities
Lead and manage internal clinical monitoring activities across multiple studies and sites, ensuring 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.
Define and maintain metrics and KPIs for monitoring, safety reviews, and CAPA activities; generate dashboards and reports for leadership and stakeholders.
Identify potential risks and trends in monitoring data and develop mitigation strategies.
Drive process optimization initiatives to enhance efficiency, productivity, and compliance.
Provide leadership, guidance, and mentorship to a team of professionals.
Work closely with Clinical Operations, Data Management, Regulatory Affairs, and external vendors; support study teams in communicating and managing complex quality issues with external sponsors.
Oversee relationships with external vendors, CROs and other third‑party service providers; manage budgets and resource allocation.
Maintain accurate and complete monitoring documentation, generate metrics and reports for senior leadership and stakeholders.
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
Master’s degree preferred.
Clinical research‑related certification preferred.
The annual base salary range for this position is $139,984 to $221,249, and pay will be based on experience and qualifications. This position is not eligible for H1‑B sponsorship at this time.
Benefits 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).
Additional Information We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If you need assistance or a reasonable accommodation during the application or recruiting process due to a disability, please send a request to Human Resources at hrops@fredhutch.org or call 206‑667‑4700.
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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.
Assistant Director, Clinical Research Monitoring Program 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.
Responsibilities
Lead and manage internal clinical monitoring activities across multiple studies and sites, ensuring 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.
Define and maintain metrics and KPIs for monitoring, safety reviews, and CAPA activities; generate dashboards and reports for leadership and stakeholders.
Identify potential risks and trends in monitoring data and develop mitigation strategies.
Drive process optimization initiatives to enhance efficiency, productivity, and compliance.
Provide leadership, guidance, and mentorship to a team of professionals.
Work closely with Clinical Operations, Data Management, Regulatory Affairs, and external vendors; support study teams in communicating and managing complex quality issues with external sponsors.
Oversee relationships with external vendors, CROs and other third‑party service providers; manage budgets and resource allocation.
Maintain accurate and complete monitoring documentation, generate metrics and reports for senior leadership and stakeholders.
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
Master’s degree preferred.
Clinical research‑related certification preferred.
The annual base salary range for this position is $139,984 to $221,249, and pay will be based on experience and qualifications. This position is not eligible for H1‑B sponsorship at this time.
Benefits 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).
Additional Information We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If you need assistance or a reasonable accommodation during the application or recruiting process due to a disability, please send a request to Human Resources at hrops@fredhutch.org or call 206‑667‑4700.
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