Clinical Trial Assistant

About the role

The Clinical Trial Assistant provides day-to-day operational support for clinical studies and helps ensure that outsourced clinical trials are planned, executed, and closed out efficiently and in full compliance with protocols, ICH Good Clinical Practice (GCP), applicable regulatory requirements, and standard operating procedures. This role closely supports the clinical operations project team and Clinical Trial Manager, contributes to vendor and site management, and helps maintain the integrity and quality of clinical trial documentation and processes.

Responsibilities

• Support the clinical operations project team in the daily management of clinical studies, contributing to planning, execution, and closeout activities for outsourced clinical trials.
• Develop, format, and distribute meeting agendas, minutes, and monthly status reports to document key project updates and ensure timely communication to relevant stakeholders.
• Support Clinical Trial Management in communications with contract research organizations (CROs), vendors, and investigator sites to maintain alignment on study activities and timelines.
• Assist the Clinical Trial Manager with study start-up activities, including preparing and/or reviewing study-related documents such as Monitoring Plans, Laboratory Manuals, Patient Diaries, Clinical Site Procedures Manuals, Pharmacy Manuals, CRF Completion Guidelines, study logs and forms, and other trial documentation.
• Support the preparation, review, and tracking of site contracts and budgets, as well as vendor contracts and budgets, to facilitate timely study initiation.
• Assist in tracking subject recruitment at all study sites, including monitoring visit schedules and approvals, and help identify infringements, breaches, misconduct, fraud, negative trends, and protocol deviations.
• Notify CROs and investigator sites of updates on global study information to ensure that all parties remain informed of study changes and developments.
• Assist the project team in the collection, review, and filing of site essential documents, ensuring accurate and complete maintenance of the Trial Master File (TMF).
• Support the tracking and reconciliation of clinical supplies at sites in coordination with systems such as Interactive Web Response Systems (IWRS), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS).
• Follow international GCP guidelines, applicable regulations, and standard operating procedures when executing clinical study activities.
• Support the Clinical Trial Manager in formal risk assessment activities, including the review of issues and development of corrective action plans across the study.
• Participate in the planning of quality assurance activities and internal and external audits or inspections, and help coordinate communication of audit and inspection findings.
• Participate in regular internal team meetings and teleconferences, as well as meetings with CROs, vendors, and investigator sites, including Investigator Meetings as needed.
• Promptly communicate any out-of-scope issues or concerns to the Clinical Trial Manager as soon as they are identified.
• Collaborate and communicate effectively with cross-functional study team members to support coordinated study execution.
• Perform other related duties as assigned to support the successful conduct and completion of clinical trials.

Requirements

• Demonstrated experience operating effectively in a clinical environment.
• Experience working with clinical protocols and understanding of protocol requirements.
• Working knowledge of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
• Experience with clinical trial processes such as study start-up, TMF management, and study documentation.
• Familiarity with systems and tools commonly used in clinical trials, including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Interactive Web Response Systems (IWRS).
• Strong verbal communication skills, with the ability to interact clearly and professionally with internal teams, CROs, vendors, and investigator sites.
• Strong written communication skills, including the ability to draft and edit meeting agendas, minutes, status reports, and study-related documentation.
• Excellent organizational skills with the ability to manage multiple tasks and priorities in a fast-paced environment.
• Effective time management skills and the ability to meet deadlines while maintaining attention to detail.
• Ability to follow standard operating procedures and regulatory guidelines consistently in all aspects of clinical trial support.
• Bachelor's degree in a scientific discipline or related field.
• Understanding of clinical research processes, including clinical trial conduct and study lifecycle management.
• Experience with clinical trial start-up activities, including preparation and review of study documents and site essential documents.
• Familiarity with Trial Master File (TMF) maintenance and document control practices.
• Knowledge of subject recruitment tracking and monitoring visit coordination.
• Ability to contribute to risk assessment discussions and support the development of corrective action plans.
• Comfort working cross-functionally with clinical operations, quality assurance, and external partners such as CROs and vendors.
• Strong attention to detail and a quality-focused mindset when handling clinical trial documentation and data.
• Proactive approach to identifying issues and escalating out-of-scope items to the Clinical Trial Manager.

Work environment

This role operates in an on-site, office-based clinical research environment, working Monday through Friday. The position involves close collaboration with clinical operations teams, CROs, vendors, and investigator sites, primarily through meetings, teleconferences, and electronic communication. You will work regularly with clinical trial technologies and systems, including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Interactive Web Response Systems (IWRS), as well as standard office productivity tools. The work setting emphasizes adherence to GCP, regulatory requirements, and internal standard operating procedures, with a strong focus on documentation quality, audit readiness, and cross-functional teamwork.

Pay and benefits

The pay range for this position is $53.00 - $53.80/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan (Pre-tax and Roth post-tax contributions available)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job details

This is a Contract position based out of Seattle, WA. The role is fully onsite in Seattle, WA. The position is anticipated to close on Nov 2, 2026.