Clinical Trial Assistant (CTA)

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

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