Clinical Trial Assistant

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 elevate 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 elevate 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. #J-18808-Ljbffr Meet Life Sciences Ltd.