Clinical Trial Associate

Generate Biomedicines

. Support execution of Phase 3 clinical trials, including global site activation, study conduct, and closeout activities .

Posted 11/11/2026full-timeRemote • United StatesJuniorMid-Level💰 $79,000 - $103,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing Phase 3 clinical trials, including Trial Master File (TMF) management, regulatory compliance, and collaboration with CROs. Proficient in clinical systems and skilled in organizational and problem-solving capabilities to ensure successful trial execution.

Highest-signal resume keywords

Phase 3 Clinical Trials SupportTrial Master File ManagementClinical Systems Proficiency (eTMF, CTMS)FDA and ICH-GCP KnowledgeRegulatory Documentation Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory ComplianceData Quality ManagementProtocol Deviation IdentificationBudget TrackingTimeline TrackingRisk Mitigation PlanningClinical Audit ReadinessEssential Regulatory Documentation CollectionStudy Design Understanding

Soft Skills

Strong Organizational SkillsProblem-Solving SkillsEffective Communication SkillsTask PrioritizationCollaboration

Tools & Technologies

MS Office (Word, Excel, PowerPoint)ETMFCTMS

Industry Keywords

Clinical TrialsCRO CollaborationRegulatory RequirementsInformed Consent TrackingProtocol Amendment TrackingMonitoring Visit ReportsKPI ReviewStudy ConductCloseout ActivitiesSite Management Practices

About the role

Key responsibilities & impact

Support execution of Phase 3 clinical trials, including global site activation, study conduct, and closeout activities
Manage Trial Master File (TMF) setup, maintenance, and quality control
Collaborate with CROs to review monitoring visit reports, protocol deviations, and KPIs
Coordinate with internal teams and vendors to align trial activities with regulatory requirements
Assist with collection and review of essential regulatory documentation
Organize study meetings and manage action and decision logs
Track timelines, escalate risks or delays, and contribute to mitigation planning
Support clinical audit readiness, document review, reconciliation, and regulatory filing preparation
Maintain informed consent and protocol amendment tracking across global trial sites
Assist with clinical vendor invoice reconciliation and budget tracking

Requirements

What you’ll need

Bachelor’s degree; life sciences or related degree preferred
2+ years of experience supporting Phase 3 clinical trials at a sponsor or CRO
Proficiency in clinical systems (eTMF, CTMS)
Knowledge of FDA and ICH-GCP requirements for pivotal studies
Strong organizational, problem-solving, and communication skills
Understanding of the clinical drug development process, including study design, protocol objectives, and operational impacts
Understanding of site management and monitoring practices, data quality/integrity, and protocol deviation identification and reporting
Proficiency in MS Office applications, including Word, Excel, and PowerPoint
Basic understanding of current ICH-GCP regulations/guidelines
Able to manage and prioritize competing tasks in a fast-paced environment

Benefits

Comp & perks

Annual bonus eligibility
Equity compensation
Competitive benefits package
Minimal travel (no more than 10–20% for monitoring-related work)