Remote Clinical Trial Assistant — Close-Out & TMF Specialist

K-Recruiting GmbH; United States; Remote; USD 39,000 - 52,000; Part time

Job summary

KRecruting GmbH is seeking a Clinical Trial Assistant to support study close-out activities in a remote, EST-friendly environment. You will manage TMF documentation, assist with essential study documents, and coordinate with CRAs, vendors, and study teams to ensure audit readiness.

The role emphasizes strong organizational and communication skills, familiarity with GCP/ICH guidelines, and experience in TMF/eTMF within pharma/biotech/CRO settings.

Qualifications

• Minimum CTA experience in pharma/biotech/CRO environment.
• Experience supporting clinical study close-out activities.
• Familiarity with GCP/ICH guidelines and trial documentation requirements.
• Experience with TMF/eTMF and document management systems.
• Strong organizational and communication skills.
• Ability to work remotely and manage multiple tasks.

Responsibilities

• Support clinical study close-out activities per timelines and regulatory requirements.
• Maintain and reconcile TMF documentation and study budgets.
• Assist with collection, review, and filing of essential study documents.
• Track and support site close-out deliverables and documentation.
• Coordinate with 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.

Skills

CTA experience

GCP/ICH knowledge

TMF management

Regulatory compliance

Remote work

Communication skills

Organizational skills

Job description

KRecruting GmbH is seeking a Clinical Trial Assistant to support study close-out activities in a remote, EST-friendly environment. You will manage TMF documentation, assist with essential study documents, and coordinate with CRAs, vendors, and study teams to ensure audit readiness.

The role emphasizes strong organizational and communication skills, familiarity with GCP/ICH guidelines, and experience in TMF/eTMF within pharma/biotech/CRO settings.