Clinical Trial Associate

Disc Medicine

. Support day-to-day clinical study activities, including inspection readiness and oversight of inspection deliverables and milestones .

Posted 9/16/2026full-timeWatertown • Massachusetts • United StatesJuniorMid-Level💰 $76,000 - $92,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study management, including oversight of documentation, compliance with FDA and ICH GCP guidelines, and effective collaboration with cross-functional teams. Proficient in managing timelines, budgets, and communication within clinical trial environments.

Highest-signal resume keywords

Clinical Study ManagementFDA Guidelines UnderstandingICH GCP ComplianceMS Office ProficiencyProject Team Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Documentation DevelopmentTrial Master File ManagementPatient Sample TrackingBudget ManagementSOP Preparation

Soft Skills

Effective CollaborationStrong OrganizationRelationship-BuildingCommunication SkillsInitiative and Ownership

Tools & Technologies

MS WordMS ExcelMS PowerPointMS Outlook

Industry Keywords

Clinical TrialsInspection ReadinessStudy Start-Up ActivitiesClinical MonitoringIRB Questions

About the role

Key responsibilities & impact

Support day-to-day clinical study activities, including inspection readiness and oversight of inspection deliverables and milestones
Collaborate with Clinical Trial Managers, study teams, vendors, and CROs on clinical study activities
Prepare and coordinate bi-weekly clinical trial team meetings and track action items
Develop, review, and approve study documentation and essential document packets
Contribute to clinical documents including protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, laboratory manuals, pharmacy manuals, and trial status updates
Ensure clinical trial documentation and the trial master file remain audit-ready
Track patient samples and reconcile discrepancies with sites and central labs
Assist with invoices, clinical projections, and per-patient cost estimates
Support study and site start-up activities, including SIV slides, process flows, contract and budget negotiations, site ICF customizations, and IRB questions
Review clinical monitoring visit reports and ensure follow-up items are closed
Collaborate with Legal, Finance, Nonclinical, CROs, and external vendors
Maintain trial-related processes and systems with study vendors
Develop and drive timelines for data cuts, conference needs, and interim analyses
Monitor and report clinical trial progress, budgets, and timelines
Maintain patient trackers and follow up on outstanding patient visits
Initiate ClinicalTrials.gov updates and publications
Participate in preparing and reviewing SOPs
Perform other business needs identified by the direct line manager

Requirements

What you’ll need

BA/BS required
Understanding of FDA and ICH GCP guidelines
Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
Ability to collaborate effectively with internal and external study teams
Ability to take initiative and ownership of new activities
Ability to work in a fast-paced environment and manage multiple competing tasks and demands
Experience working on project teams required
Strong organization, relationship-building, and communication skills

Benefits

Comp & perks

Hybrid work environment with flexibility to work remotely or from headquarters
Comprehensive benefits
Competitive compensation package
Flexible work environment
Career growth opportunities
Inclusive company culture