TMF Specialist I (FHI Clinical)

Summary of the Position: The TMF Specialist I is responsible to deliver controlled and quality trial master file documents for the purposes of regulatory and health authority inspections; and to ensure compliance as delegated by trial sponsors and under applicable institutional policy. Essential Functions: Responsible for paper Trial Master File (TMF) set-up, maintenance, update, archival and destruction (if applicable) in accordance with FHI Clinical processes, Sponsor requirements, and applicable regulations. Responsible for comprehensive review and approval of TMF/eTMF Management plans. Responsible for assessing training needs of staff regarding TMF/eTMF document delivery and implementing training (individual and/or departmental). Responsible for maintaining systems and tools for evaluating, tracking, and transmitting trial master file documents. Ensure adequate set-up of master files including proper and timely filing of all relevant study documents. Maintain documents master files according to regulatory and company-defined standards. Conduct detailed and appropriate quality checks on TMF/eTMF documents at defined timepoints, including any paper originals required. Conduct TMF/eTMF content reviews and provide TMF/eTMF content reports on a regular basis. Ensure that FHI Clinical privacy and security standards are met and adhered to.  Ensure that documents are maintained in accordance with FHI Clinical retention practices. Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Policy & Procedures, FDA and ICH GCP guidelines. Participate in organizational process improvements as required. Assists with maintaining up-to-date study status tracking and other tracking tools (as assigned) Knowledge, Skills and Abilities: Ability to work well with people and establish effective relationships across all levels of the organization. Strong computer skills (MS Office), SharePoint, and Acrobat. Ability to format and publish large documents and create and maintain tracking systems and spreadsheets. Ability to coordinate review and finalization of documents with multiple stakeholders. Aptitude to learn additional software programs and databases quickly. Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner. Ability to work effectively under pressure of deadlines. Demonstrated ability to make decisions involving conflicts of interest. Excellent attention to detail. Knowledge of clinical trial design, execution, and operations. Must be able to read, write and speak fluent English Position Requirements: Education: High school diploma required. Preferred Job-related Experience: 1-3 Years of documentation management and experience with FDA, ICH, and GCP guidelines. Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practice