Clinical Trial Assistant (CTA) – TMF / eTMF Quality Control | Remote, USA
Company: ICON plc
Job Type: Full-Time
Work Model: Remote
Location: United States
Experience Required: Minimum 3–6+ Years in Clinical Trial Support with Direct TMF/eTMF Quality Control Experience
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization providing full-service clinical development solutions to pharmaceutical, biotechnology, and medical device companies. ICON supports sponsors across all phases of clinical research, ensuring regulatory compliance, data integrity, and operational excellence worldwide.
Job Overview
ICON is hiring a Clinical Trial Assistant (CTA) – TMF to support Trial Master File (TMF) operations with a strong focus on eTMF quality control, documentation integrity, and inspection readiness.
This remote role is ideal for clinical research professionals with hands-on experience reviewing TMF content, ensuring cross-document consistency, and maintaining regulatory compliance across study documentation. The CTA will work closely with cross-functional study teams to ensure TMF accuracy, completeness, and audit readiness throughout the trial lifecycle.
Key Responsibilities
TMF and eTMF Quality Control
Perform detailed eTMF quality control (QC) reviews to assess document accuracy, completeness, and compliance.
Evaluate cross-document consistency and alignment across TMF sections.
Identify documentation gaps, discrepancies, and quality risks.
Ensure TMF structure aligns with regulatory expectations and internal standards.
Support ongoing inspection readiness initiatives.
Clinical Trial Administrative Support
Provide administrative support for clinical studies, including documentation management and record maintenance.
Assist in preparing and submitting regulatory documents in compliance with study protocols.
Maintain accurate and timely filing within electronic Trial Master File systems.
Cross-Functional Collaboration
Partner with Clinical Operations, Regulatory Affairs, and Quality teams to resolve TMF-related issues.
Support study teams in maintaining documentation consistency and compliance.
Facilitate communication between internal stakeholders and study sites as needed.
Tracking and Reporting
Monitor TMF completeness metrics and provide status updates to study leadership.
Track document collection timelines and escalate risks when necessary.
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Healthcare, Clinical Research, or related discipline preferred.
Minimum 3–6+ years of experience in a clinical trial support role within a CRO or pharmaceutical organization, with direct exposure to TMF/eTMF processes.
Proven hands-on experience performing eTMF/TMF quality control reviews beyond basic administrative checks.
Strong knowledge of TMF reference models and regulatory expectations (ICH-GCP, FDA, EMA).
Experience identifying documentation gaps, inconsistencies, and compliance risks.
Proficiency in eTMF systems and clinical trial management platforms.
Excellent organizational, analytical, and documentation review skills.
Strong written and verbal communication skills with the ability to collaborate in a remote, global team environment.
Preferred Competencies
Experience supporting inspection or audit readiness activities.
Familiarity with multi-regional or global clinical trials.
Knowledge of risk-based quality management principles.
Ability to manage multiple studies simultaneously in a fast-paced environment.
Compensation and Benefits
ICON offers competitive compensation aligned with industry standards and geographic markets. The comprehensive benefits package may include:
Paid annual leave
Health and medical insurance plans
Retirement savings programs
Life assurance
Employee Assistance Programs
Flexible, country-specific benefits
ICON is committed to fostering an inclusive workplace and providing equal employment opportunities to all qualified applicants.
Who Should Apply
This role is ideal for:
Clinical Trial Assistants with TMF specialization
eTMF Quality Control Specialists
TMF Reviewers
Clinical Documentation Specialists
Clinical Operations Support Professionals
If you have strong expertise in Trial Master File management and are seeking a remote opportunity within a global CRO environment, this role offers direct involvement in inspection readiness and clinical quality oversight.
For more global clinical research, regulatory affairs, TMF, pharmacovigilance, and CRO job opportunities, visit ThePharmaDaily.com.
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