Clinical Trial Associate

Role Summary

Clinical Trial Associate. Hybrid role with remote and Watertown, MA office options. Lead planning, implementation, and management of early-phase clinical research studies as part of the Clinical Operations team.

Responsibilities

• Provide support for day-to-day clinical study activities, including inspection readiness and oversight of inspection deliverables and milestones, under the supervision of the CTA Manager.
• Collaborate with the Clinical Trial Manager, study teams, vendors, and CROs to support clinical study activities defined by the clinical trial operating model.
• Prepare and coordinate bi-weekly clinical trial team meetings; finalize agendas, slides, and minutes; track and follow up on action items.
• Develop and/or review study documentation, including essential document packets, study plans, and informed consent forms.
• Contribute to writing and reviewing clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, and manuals.
• Ensure audit-ready trial documentation, including the trial master file; lead internal TMF quality reviews with cross-functional team members.
• Track patient samples and reconcile discrepancies with sites and central labs; coordinate sample movement and data deliverables on time.
• Assist finance with invoices, projections, and per-patient cost estimates.
• Work with CRO to support study and site start-up activities (SIV slides, processes, budgets, site ICFs, IRB questions) to meet timelines.
• Review clinical monitoring visit reports and ensure follow-up items are resolved promptly.
• Collaborate with Legal, Finance, Nonclinical, CROs, and external vendors.
• Establish and maintain trial-related processes/systems with study vendors (central labs, clinical supplies, IP depot, CRO) as required.
• Develop and drive timelines; align cross-functional teams on deliverables for data cuts, conference needs, and interim analyses.
• Monitor progress of clinical study activities; report on budget and timelines.
• Maintain patient trackers; ensure timely visits; provide real-time updates to the Clinical Trial Team as needed.
• Initiate clinicaltrials.gov updates and publications as needed.
• Participate in the preparation and review of SOPs.
• Perform other duties as assigned by the direct supervisor.

Qualifications

• BA/BS required
• Understanding of FDA and ICH GCP guidelines
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to collaborate with internal and external study teams
• Initiative and ownership of new activities
• Ability to work in a fast-paced environment with multiple tasks
• Experience working on project teams
• Self-driven with strong organizational, relationship-building, and communication skills

Skills

• Operational planning and execution of clinical studies
• Documentation management and TMF quality assurance
• Vendor and CRO coordination
• Budget tracking and financial involvement related to clinical trials
• Cross-functional collaboration and communication

Education

• BA/BS required