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Clinical Trial Assistant (CTA) (m/w/d)

Vertraulich · Deutschland · Remote · Senior

  • Deutschland · Remote
  • 6 months
  • English

Indexiert (vor 13 Tagen) · laufend aktualisiert

Start
ASAP
Laufzeit
6 months
Arbeitsmodell
Remote
Vertrag
Freelance / B2B
Erfahrungslevel
Senior
Referenz
POS09669

Geforderte Skills

Sprachen: English

Jobbeschreibung

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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