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Clinical Trial Assistant – Contract to Hire
TransPerfect. Support Clinical Operations and study leadership with day-to-day coordination and administration of assigned clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial coordination, including managing study documentation, maintaining regulatory compliance, and supporting trial master file activities. Proficient in utilizing clinical trial management systems and Microsoft Office tools to enhance operational efficiency.
Highest-signal resume keywords
Clinical Trial CoordinationTrial Master File (TMF) ManagementGood Clinical Practice (GCP)Clinical Trial Management System (CTMS)Regulatory Documentation Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchStudy Tracker MaintenanceDocument Version ControlRegulatory ComplianceMeeting CoordinationAction Log ManagementFeasibility AssessmentSite Activation TrackingStudy Close-Out SupportInformed Consent Form Review
Soft Skills
Strong Organizational SkillsEffective Communication SkillsAttention to DetailAbility to Manage Multiple PrioritiesCollaborative Teamwork
Tools & Technologies
Microsoft Office SuiteElectronic Document Management SystemsClinical Trial Technology PlatformsStudy DashboardsAction Item Trackers
Industry Keywords
Clinical OperationsPharmaceutical IndustryBiotechnology IndustryContract Research Organization (CRO)Rare Disease Clinical Development
About the role
Key responsibilities & impact- 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
- Maintain current investigator and site information
- 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 and escalate risks, issues, or delays
- Support study close-out, including outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other required records
- Prepare, review, route, and track study documents
- Compile and maintain study reference materials and manuals
- Maintain document version control and ensure current approved materials are available
- Maintain study folders, shared workspaces, and electronic repositories
- Support Trial Master File activities, including document collection, filing, quality review, reconciliation, and follow-up on missing or incomplete documents
- 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
- Assist with third-party vendor coordination and tracking
- Support Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities
- Help develop and revise SOPs, templates, forms, work instructions, and Clinical Operations tools
- Recommend improvements to study processes, trackers, templates, and workflows
- Perform other clinical trial support activities consistent with assigned studies and training and experience
Requirements
What you’ll need- 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
- Candidates must be English-speaking
- Candidates must be in a workable time zone for the study team
- Experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site is preferred
- Experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms is preferred
- Experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation is preferred
- Experience supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out is preferred
- Experience coordinating or supporting third-party vendors is preferred
- Experience supporting rare disease, pediatric, or other complex clinical development programs is a plus
Benefits
Comp & perks- Contract-to-hire opportunity
- Remote work
- Full-time schedule
- Opportunity to support clinical trials for a global language and technology solutions company’s client