Clinical Trial Assistant - Contract to Hire

TransPerfect is sourcing this role on behalf of our client, a contract research organization (CRO). Candidates will apply through TransPerfect. Position Overview - Type: Full-time, 12-month contract-to-hire - Location: Remote. Candidates may be US-based or international, provided they are English-speaking. - Time zone: Candidates must be in a workable time zone for the study team. - Openings: One Clinical Trial Assistant (CTA) to support assigned clinical trials. Key Responsibilities Study Coordination and Communication - Support Clinical Operations and study leadership with day-to-day coordination and administration of assigned clinical trials. - Schedule and coordinate study meetings. Prepare agendas, presentation materials, minutes, action items, and follow-up documentation. - Maintain study trackers, action logs, metrics, dashboards, and other tools used to monitor study progress and deliverables. - Communicate with clinical trial sites about routine study activities and documentation, as directed by the Project Manager, CRA, or other designated team member. - Maintain current investigator and site information, including contact details, site status, and required documentation. Study Start-Up, Conduct, and Close-Out - Collect and organize information for site feasibility, site identification, and site selection. - Support study-specific training materials, investigator meetings, site initiation activities, and other study meetings. - Track start-up and site activation, enrollment, monitoring visits, outstanding documents, milestones, and other deliverables. - Identify overdue or potentially delayed activities. Escalate risks, issues, or delays to the appropriate team member. - Support study close-out, including tracking outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other required records. Document Management - Assist with preparing, reviewing, routing, and tracking study documents, including informed consent forms, study manuals, plans, forms, and templates. - Compile and maintain study reference materials and manuals, including regulatory, pharmacy, laboratory, monitoring, and other study-specific documentation. - Maintain document version control. Help ensure current approved materials are available to study team members and sites. - Maintain study folders, shared workspaces, and electronic repositories according to established filing structures and access requirements. Trial Master File (TMF) and Regulatory Documentation - Support TMF activities, including document collection, filing, quality review, reconciliation, tracking of missing or incomplete documents, and follow-up with responsible parties. - Help ensure study documentation is complete, accurate, appropriately approved or executed, and stored in the designated repository. - Track and collect essential regulatory and study documents, including Form FDA 1572s, Financial Disclosure Forms, investigator qualifications, licenses, and training documentation. - Support clinical trial registry activities by compiling and tracking information for registrations and updates, as directed. Vendor Management - Assist with third-party vendor coordination and tracking, including deliverables, documentation, meetings, action items, and follow-up, as assigned. Quality and Process Improvement - Support preparation for Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities. - Help develop and revise SOPs, templates, forms, work instructions, and other Clinical Operations tools. - Recommend practical improvements to study processes, trackers, templates, and workflows to Clinical Operations leadership. - Perform other clinical trial support activities consistent with the needs of assigned studies and the individual's training and experience. Minimum Qualifications - Bachelor's degree in life sciences, healthcare, business, or a related field, or an equivalent combination of education and relevant experience. - Approximately 3 years of experience in clinical research, clinical operations, the pharmaceutical or biotechnology industry, or a CRO. - General understanding of clinical trial conduct and Good Clinical Practice (GCP). - Strong organizational skills. Ability to manage multiple priorities, deadlines, documents, and study activities at once. - Strong attention to detail and commitment to accurate, complete documentation. - Effective written and verbal communication skills. - Ability to work collaboratively with Sponsors, clinical sites, CRAs, vendors, and internal team members. - Ability to work independently within assigned responsibilities and escalate questions, risks, or issues appropriately. - Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams. Preferred Qualifications - Experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site. - Experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms. - Experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation. - Experience supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out. - Experience coordinating or supporting third-party vendors. - Experience supporting rare disease, pediatric, or other complex clinical development programs is a plus. About TransPerfect TransPerfect is a global leader in language and technology solutions. It is sourcing this role on behalf of its client. Interested candidates should apply through TransPerfect.