Clinical Research Manager
About The Position
The Clinical Research Manager provides strategic and operational oversight of complex, multi-site clinical research projects at Virginia Mason Medical Center, collaborating with Principal Investigators, Benaroya Research Institute, sponsors, and internal and external stakeholders. The role manages industry-sponsored, NIH-funded, and investigator-initiated trials, ensuring regulatory compliance, financial accountability, and timely achievement of study milestones. The Manager also supervises research staff and supports the integration of clinical research into standard care workflows. The position oversees studies across inpatient and outpatient settings, manages budgets and contracts, monitors study progress, supports regulatory submissions, and coordinates with investigators, sponsors, contract research organizations, and multidisciplinary departments.
Requirements
- Bachelor’s degree required.
- Minimum of five years of experience managing human subjects research and/or laboratory science projects in clinical research.
- Demonstrated experience in staff supervision, research operations, and complex project management.
- Knowledge of clinical research regulations, IRB processes, GCP, and biomedical research requirements.
- Proficiency in Microsoft Office, 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.
Nice To Haves
- Advanced degree preferred.
- Experience developing and managing research budgets, contracts, timelines, and study milestones preferred.
- Clinical research certification through ACRP or SOCRA strongly preferred.
Responsibilities
- Lead the planning, coordination, execution, and oversight of multiple complex clinical research studies across inpatient and outpatient settings.
- Supervise and support Clinical Research Coordinators and Research Assistants, fostering professional development and effective team performance.
- Develop, negotiate, and manage study budgets, contracts, invoicing, and financial reporting.
- 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.
Benefits
- Medical, dental, and vision insurance.
- Flexible spending accounts for health care, dependent care, and commuter expenses.
- Short- and long-term disability insurance.
- Life and AD&D insurance.
- 403(b) retirement plan with matching funds after one year of employment.
- PTO including 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
