CRO – TMF Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Review, process, and approve documents for the Trial Master File (TMF) submitted to the electronic TMF (eTMF), ensuring they align with the electronic Investigator Site File (ISF) and specific study filing requirements.

• Validate the quality of documents by checking the accuracy of metadata, adherence to naming conventions, and version control prior to approval.

• Collaborate with internal stakeholders to resolve document discrepancies and ensure timely resolutions.

• File documents promptly to keep a complete, inspection-ready TMF throughout the study lifecycle.

• Update and monitor the Expected Documents List (EDL) in accordance with sponsor expectations and regulatory standards.

• Utilize designated systems and tools to manage document flow, track submissions, and identify potential quality issues.

• Assist in retrieving outdated or missing documents as necessary.

• Provide operational support to Regulatory Specialists and Senior TMF Specialists, including the collection and preliminary review of Essential Documents.

• Participate in TMF audit preparation and support audit response efforts by organizing and verifying documentation.

• Contribute to TMF process improvement initiatives and department goals aimed at enhancing document quality and compliance.

• Address document-related inquiries from internal teams and external partners, escalating complex issues as needed.

• Stay informed about Lotus CRO and Sponsor SOPs, TMF best practices, and relevant regulatory guidelines; recommend workflow enhancements.

• Assist with the intake and categorization of documents from sites and vendors, ensuring accurate routing and timely processing.

• Monitor TMF completeness reports and escalate any gaps or delays to senior staff.

⛳️ Requirements

• Minimum of 1 year of experience in clinical research, document management, or regulatory operations.

• Experience with electronic document management systems and eTMF platforms; Veeva eTMF experience is highly preferred.

• Familiarity with Good Clinical Practices (GCP), ICH guidelines, and the DIA TMF Reference Model is desirable.

• Knowledge of regulatory requirements for clinical research, including GCP and ICH guidelines.

• Understanding of GCP, regulations/guidelines, auditing processes, and compliance requirements related to TMF.

• Strong working knowledge of the DIA TMF Reference Model is preferred.

• Excellent understanding of procedures and guidelines in Clinical Research.

• Strong organizational and coordination skills.

• Solid grasp of the clinical drug development process.

• Exceptional written and verbal communication skills.

• Outstanding attention to detail.

• Strong interpersonal skills.

• Proficient in Microsoft Office.

• Effective time management and organizational abilities.

• Capability to manage multiple tasks simultaneously.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work hours and remote work options.

• Supportive and collaborative work environment.