The posting
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.
