Clinical Research Manager

Benaroya Research Institute

Seattle, WAOnsitePosted 11 days ago$109,970 - $179,250 annually

Full TimeSenior LevelClinical DevelopmentResearch Institute

Summary

The Clinical Research Manager provides strategic and operational oversight of complex, multi-site clinical research projects at Virginia Mason Medical Center (VM), 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 trials, ensuring regulatory compliance, financial accountability, and timely achievement of study milestones. The Manager also oversees research staff and supports the integration of clinical research into standard care workflows.

Job description

Overview

Responsibilities

Lead the planning, coordination, execution, and oversight of multiple complex clinical research studies across inpatient and outpatient settings.
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, contracts, invoicing, and financial reporting to 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 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.
Experience developing and managing research budgets, contracts, timelines, and study milestones preferred.
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.
Clinical research certification through ACRP or SOCRA strongly preferred.

Requirements

Bachelor’s degree required; advanced degree preferred.
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.
Experience developing and managing research budgets, contracts, timelines, and study milestones preferred.
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.
Clinical research certification through ACRP or SOCRA strongly preferred.

Benefits

Medical, Dental & Vision
Flexible Spending Accounts
Short & Long-Term Disability
Life & AD&D Insurance
403(b) Retirement Plan
Paid Time Off
Employee Assistance Program
Educational Assistance Program
Subsidized ORCA Pass
Wellness Benefits
Voluntary Benefits

Company overview

Benaroya Research Institute (BRI) is a premier non-profit biomedical research organization founded in 1956 and based in Seattle, Washington. As an affiliate of Virginia Mason Health System, BRI specializes in cutting-edge research focused on the immune system and autoimmune diseases. The institute conducts comprehensive basic, clinical, and translational research aimed at understanding immune cell function and dysfunction, with particular emphasis on conditions such as type 1 diabetes, rheumatoid arthritis, multiple sclerosis, lupus, and allergies. BRI maintains extensive biorepositories containing over 350,000 samples from more than 16,000 participants, supporting both internal research and global scientific collaborations. The institute has made groundbreaking contributions including the development of MHC Class II tetramers for immune cell research, discovery of the Th2A allergy cell, and playing a key role in the development of teplizumab - the first drug to delay the onset of type 1 diabetes. With a mission to predict, prevent, reverse, and cure immune system diseases, BRI operates through multiple core laboratories and leads major research consortia including the Immune Tolerance Network, positioning itself as a global leader in immunology research and therapeutic development.