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.