The Steely Group Hiring for Clinical Documentation Associate at United States Full Time

This position supports and maintains the Trial Master File (TMF) for study teams. They also facilitate providing teams and partners with TMF Health updates to support inspection readiness.

Responsibilities:

• Review of Trial Master File (TMF) and electronic TMF (eTMF) study documents (including first pass quality review of documents as assigned), e.g., site monitoring visit s, site startup essential documents.
• Follow processes and procedures to support set up, maintenance, and archiving of TMF for assigned projects.
• Classify and index TMF documents with accurate attributes and metadata according to department standards.
• Monitor TMF health/ metrics throughout the study according to TMF plan; identify and record quality issues; provide solutions and resolve issues, as appropriate.
• Train/mentor departmental and vendor staff on TMF management systems and processes.
• Serve as TMF contact and Subject Matter Expert for the clinical study team and supporting cross-functional departments to ensure high quality documentation.
• Support audit/inspection activities, internal Compliance/Quality procedures and process improvement when requested.
• Accountable for delivery of assigned TMF activities in accordance with project requirements/timelines and as outlined in the TMF Plan.
• Assist in management of internal and external assessments and corrective/preventive actions.
• Assist in maintaining the integrity of the Clinical secure file room storage area(s).
• Manage Expected Document Lists and Milestones in Veeva eTMF
• Submit Veeva eTMF User Access Requests
• Assist with assignment of Read and Understood trainings in Veeva eTMF
• Assist with periodic TMF oversight reviews and final TMF reconciliation
• Assist with creation/updates for study TMF Plans and Reference Models
• Perform/volunteer for other duties and special projects as assigned or appropriate for skill set.

Qualifications and Skills Required:

• BA/BS is required.
• 5 years clinical experience including organizing and coordinating Trial Master Files for clinical trials.
• Good organizational and problem-solving skills, able to work independently.
• Efficient and effective time management skills with ability to successfully manage competing priorities.
• Familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted). GCP inspection experience preferred.
• High level of competency with Veeva eTMF and knowledge of the TMF Reference Model, supported by DIA.
• Proficient in Microsoft Word, Excel, and PowerPoint. Must be able to handle multiple projects at a time and have strong attention to detail.
• Able to quickly learn and adapt to new systems and technology.
• Ability to establish and maintain effective working relationships.
• Good written and verbal communication skills including excellent command of English.
• Ability to lift file boxes of documents/files onto and off of shelves and carts.