Clinical Trial Assistant

Overview

Seeking a detail-oriented Clinical Trial Assistant professional to support the day-to-day execution and management of outsourced clinical studies for a biopharmaceutical organization. This 12-month contract opportunity is based in Seattle, WA, and will focus on clinical trial coordination, study start-up, documentation, vendor management, site communication, and compliance with clinical research regulations and protocols. The ideal candidate will have a bachelor's degree in biomedical sciences or a related scientific discipline, at least 2 years of clinical research experience, and a strong understanding of clinical trial processes and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.

Key Responsibilities

• Support the day-to-day management and execution of outsourced clinical trials, including study planning, implementation, monitoring, and closeout activities.
• Assist the Clinical Trial Manager with coordinating clinical operations activities and communicating with Contract Research Organizations (CROs), vendors, investigator sites, and cross-functional study teams.
• Prepare and distribute meeting agendas, meeting minutes, monthly status reports, and other study-related communications to document project updates and track action items.
• Support study start-up activities by preparing and reviewing essential clinical trial documents, including monitoring plans, laboratory manuals, patient diaries, pharmacy manuals, clinical site procedures manuals, and Case Report Form (CRF) completion guidelines.
• Assist with the preparation and review of study logs, forms, site contracts and budgets, and vendor contracts and budgets.
• Track subject recruitment progress across study sites, monitoring visits and approvals, protocol deviations, and other study-related issues.
• Identify and escalate potential study risks, protocol violations, breaches, misconduct, fraud, negative trends, and other compliance concerns to the Clinical Trial Manager.
• Support communication of global study updates and relevant changes to CROs and investigator sites.
• Assist with collecting, reviewing, organizing, and filing essential site documents and maintaining the Trial Master File (TMF).
• Track clinical trial supplies at investigator sites in coordination with established clinical systems, including Interactive Web Response Systems (IWRS), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS).
• Follow ICH GCP guidelines, applicable regulatory requirements, study protocols, and internal standard operating procedures (SOPs) to support compliant clinical trial execution.
• Participate in formal study risk assessments, quality assurance planning, corrective and preventive action activities, and the coordination of internal and external audits and inspections.
• Coordinate communication and follow-up related to audit and inspection findings, ensuring appropriate documentation and escalation.
• Participate in regular project team meetings, CRO and vendor teleconferences, investigator site meetings, and investigator meetings as needed.
• Communicate out-of-scope activities, operational challenges, and study-related concerns to the Clinical Trial Manager promptly.
• Provide flexible support across clinical operations activities as needed to support study timelines, quality, and compliance.

Required Skills

• Bachelor's degree in Biomedical Sciences or a related scientific discipline.
• At least 2 years of clinical research experience, preferably supporting clinical trial operations in a pharmaceutical, biotechnology, or clinical research environment.
• Demonstrated experience working with clinical study protocols and supporting clinical trial activities.
• Working knowledge of ICH Good Clinical Practice (GCP) guidelines, applicable clinical research regulations, and standard operating procedures.
• Familiarity with clinical trial documentation, essential documents, and Trial Master File (TMF) maintenance.
• Strong organizational, multitasking, and time management skills, with the ability to manage multiple study activities and competing priorities.
• Excellent written and verbal communication skills, including the ability to coordinate with CROs, vendors, investigator sites, and cross-functional stakeholders.
• Exceptional attention to detail and accuracy when reviewing study documents, tracking trial activities, and maintaining records.
• Ability to identify, document, and escalate study-related issues, compliance risks, protocol deviations, and operational concerns.
• Ability to work collaboratively with Clinical Trial Managers and cross-functional project teams to support study timelines and deliverables.
• Strong problem-solving skills and the ability to work effectively in a regulated clinical research environment.

Preferred Skills

• Previous experience supporting outsourced clinical trials within the pharmaceutical or biotechnology industry.
• Experience coordinating with CROs, clinical vendors, and investigator sites.
• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and interactive response technologies (IWRS).
• Experience with Trial Master File (TMF) maintenance and essential document collection, review, and filing.
• Exposure to clinical study start-up, site monitoring activities, subject recruitment tracking, and clinical supply coordination.
• Experience supporting clinical quality activities, risk assessments, audits, inspections, and corrective action plans.
• Familiarity with study-related contracts, budgets, monitoring plans, laboratory manuals, pharmacy manuals, and other clinical trial documentation.
• Experience preparing project status reports, meeting minutes, agendas, and clinical operations communications.
• Ability to recognize study risks and compliance issues and communicate them effectively to the appropriate stakeholders.