CRO – TMF Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

📊 Conversion Rate Optimizer (CRO)

🚫👨‍🎓 No degree required

👻 Ghost score 12%

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Review, process, and approve Trial Master File (TMF) documents submitted to the electronic TMF (eTMF), ensuring alignment with the electronic Investigator Site File (ISF) and study-specific filing requirements • Validate document quality by checking metadata accuracy, naming conventions, and version control prior to approval • Communicate with internal stakeholders to clarify document discrepancies and support timely resolution • File documents promptly to maintain 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 • Use designated systems and tools to manage document flow, track submissions, and flag potential quality issues • Assist in retrieving outdated or missing documents • Provide operational support to Regulatory Specialists and Senior TMF Specialists, including collection and preliminary review of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 efforts and department initiatives enhancing document quality and compliance • Respond to document-related questions from internal teams and external partners, escalating complex issues as appropriate • Maintain familiarity with Lotus CRO and Sponsor SOPs, TMF best practices, and applicable regulatory guidelines; suggest workflow improvements • Assist with document intake and categorization from sites and vendors, ensuring accurate routing and timely processing • Monitor TMF completeness reports and escalate gaps or delays to senior staff

🎯 Requirements

• At least 1 year of experience in clinical research, document management, or regulatory operations • Experience with electronic document management systems and eTMF platforms; Veeva eTMF experience strongly preferred • Familiarity with Good Clinical Practices (GCP), ICH guidelines, and the DIA TMF Reference Model desirable • Knowledge of regulatory requirements for clinical research, including GCP and ICH guidelines • Knowledge of GCP, regulations/guidelines, auditing processes, and compliance requirements in relation to TMF • Working knowledge of the DIA TMF Reference Model strongly preferred • Strong working knowledge of procedures and guidelines in Clinical Research • Excellent organizational and coordination skills • Solid understanding of the process of clinical drug development • Strong written and verbal communication skills • Exceptional attention to detail • Strong interpersonal skills • Proficiency in Microsoft Office • Effective time management and organizational skills • Ability to handle multiple tasks simultaneously