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Clinical Trial Assistant (M/F/D)
Key Responsibilities:
Support clinical study close-out activities in accordance with study timelines and regulatory requirements.
Maintain and reconcile Trial Master File (TMF) documentation as well as study budgets.
Assist with the collection, review, and filing of essential study documents.
Track and support site close-out deliverables and documentation.
Coordinate with Clinical Research Associates (CRAs), study teams, and external vendors.
Ensure study documentation is complete, accurate, and audit-ready.
Support final archiving activities and document management processes.
Assist with study-related reports, trackers, and close-out metrics.
Facilitate communication between study sites and internal stakeholders during study closure.
Requirements:
Previous experience working as a Clinical Trial Assistant (CTA) in a pharmaceutical, biotechnology, or CRO environment.
Demonstrated experience supporting clinical study close-out activities.
Familiarity with GCP, ICH guidelines, and clinical trial documentation requirements.
Experience with Trial Master Files (TMF/eTMF) and document management systems.
Strong organizational and communication skills.
Ability to manage multiple tasks and work independently in a remote environment.
Located in North America, preferably within the Eastern Time Zone, or able to work EST business hours.
Preferred Qualifications:
Vaccines experience
Experience supporting global or multicenter clinical trials.
Knowledge of site management and clinical operations processes.
Experience collaborating with CRAs, study managers, and cross-functional teams.
Requirements:
Start: asap
Duration: until the end of Q2 2027
Capacity: at least 30 hours/week - more is welcomed
Location: based in EST time zone
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