Required skills
Languages: English
Job description
Project overview
Clinical Trial Assistant (M/F/D)
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.
- 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.
Project details
asap
until the end of Q2 2027
Capacity: at least 30 hours/week - more is welcomed
based in EST time zone
- Start: ASAP
- Duration: 6 months
- Remote: remote
- Location: DE
- Languages: English
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