Clinical Trial Assistant – Contract to Hire

TGS

. Support Clinical Operations and study leadership with day-to-day coordination and administration of assigned clinical trials .

Posted 11/9/2026full-timeRemote • New York • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 CoordinationGood Clinical Practice (GCP)Trial Master File (TMF) ManagementClinical Trial Management System (CTMS)Regulatory Documentation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchStudy DocumentationStudy Tracker MaintenanceSite Activation TrackingRegulatory ComplianceAction Log ManagementMeeting CoordinationFeasibility AssessmentDocument Version ControlQuality Review

Soft Skills

Strong Organizational SkillsEffective Communication SkillsAttention to DetailAbility to Work IndependentlyCollaborative Teamwork

Tools & Technologies

Microsoft OfficeElectronic Document Management SystemsClinical Trial Technology PlatformsTrial Master File (TMF) ToolsClinical Trial Management Systems (CTMS)

Industry Keywords

Clinical OperationsPharmaceutical IndustryBiotechnology IndustryContract Research Organization (CRO)Informed Consent Form Review

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 study progress tools
Communicate with clinical trial sites about routine study activities and documentation
Maintain investigator and site information, including contact details, site status, and required documentation
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 deliverables
Identify overdue or potentially delayed activities and escalate risks, issues, or delays
Support study close-out, including essential documents, site close-out activities, investigational product documentation, financial disclosures, and 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 (TMF) activities, including document collection, filing, quality review, reconciliation, and missing-document follow-up
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
Preferred: Experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site
Preferred: Experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms
Preferred: Experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation
Preferred: Experience supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out
Preferred: Experience coordinating or supporting third-party vendors
Preferred: Experience supporting rare disease, pediatric, or other complex clinical development programs

Benefits

Comp & perks

Contract-to-hire opportunity
Full-time position
Remote work arrangement
Opportunity to work with a global leader in language and technology solutions
Potential to transition from a 12-month contract to permanent employment