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.