OverviewThe Oncology Clinical Research Manager provides strategic and operational oversight of complex, multi-site clinical research projects at Virginia Mason Medical Center (VM) and St. Anne Hospital, in collaboration with Principal Investigators (PIs), Benaroya Research Institute (BRI), sponsors, and internal and external stakeholders. This role manages a diverse portfolio of industry-sponsored, NIH-funded, and investigator-initiated clinical research studies, ensuring regulatory compliance, financial accountability, and timely achievement of study milestones. The Manager oversees research staff and supports the integration of clinical research into standard care workflows.
Responsibilities
- Lead the planning, coordination, execution, and oversight of multiple complex clinical research studies from study start-up through close out.
- Supervise and support a team of Clinical Research Coordinators and Research Assistants, fostering professional development and effective team performance.
- Develop, negotiate, and manage study budgets, manage study finances and ensure fiscal accountability.
- Oversee study protocols, timelines, milestones, recruitment, enrollment, and progress reporting.
- Ensure compliance with IRB, FDA, NIH, IBC, Good Clinical Practice (GCP), and other applicable regulatory and funding requirements.
- Support the development of protocols, informed consent forms, grant applications, data management plans, and regulatory submissions.
- Collaborate with investigators, sponsors, contract research organizations, and multidisciplinary departments to facilitate study operations and integrate research into clinical workflows.
- Monitor project progress, identify and resolve operational challenges, and implement process improvements to support quality and efficiency.
- Support regulatory applications for investigational drugs and devices, including IND, IDE, and humanitarian-use submissions.
- Communicate project goals, priorities, risks, and status updates to stakeholders while ensuring study objectives and deadlines are met.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- Minimum of five years of experience managing human subjects research projects. Experience in oncology clinical research strongly preferred.
- Demonstrated experience in staff supervision, research operations, and complex project management.
- Knowledge of clinical research regulations, IRB processes, GCP, and biomedical research requirements.
- Experience developing and managing research budgets, contracts, timelines, and study milestones preferred.
- Proficiency in Microsoft Office and Google Workspace electronic medical records, and research databases, including data capture, export, and reporting.
- Strong written and verbal communication, interpersonal, organizational, and critical-thinking skills.
- Ability to work independently, manage competing priorities, troubleshoot challenges, and collaborate effectively across multidisciplinary teams.
- Current Good Clinical Practice and Biomedical Research training required.
Compensation
$109,970 to $179,250 annually
Benefits
- Medical, dental, vision insurance
- Flexible spending accounts: health care, dependent care, commuter
- Short and long-term disability
- Life and AD&D insurance
- 403(b) retirement plan with matching funds after one year of employment
- PTO: 13 holidays, three weeks of vacation and two weeks of sick leave per year
- Employee assistance program
- Educational assistance program
- Subsidized ORCA pass
- Wellness benefits
- Voluntary benefits
