Job Description

Job Title:  TMF/Document Specialist

Pay:  $28.00 - $31.00

Job Description:  Oversee the handling of clinical trial documents in the Trial Master File (TMF) by ensuring adherence to quality standards, regulatory requirements and Standard Operating Procedures (SOPs).

• Develop project specific TMF Plan and structure at the beginning of the trial as well as maintain and update TMF plan throughout the trial
• Create, set-up and provide ongoing maintenance of the TMF for assigned projects
• Process, scan, index, route and maintain applicable project documents for the TMF in accordance with quality standards and relevant SOPs
• Receive and inventory applicable project documents in the TMF
• Ensure the security and compliance of all documents related to active and archived projects
• Prepare inventories, assist with quality checks and reconciliation of files during the study and at study closure
• Participate in TMF audits including preparation and follow-up
• Prepare and inventory files for off-site storage, if applicable
• Provide study team reports or updates regarding status of TMF on a regular basis
• Attend project team meetings as needed
• Provide ongoing training/feedback to the team on topics related to Good Documentation Practices (GDP), ICH-GCP, pertaining to TMF and document management per study team requirements
• Maintain and foster working relationships and open communication between departments

Requirements:

• Bachelor's Degree in the Life Sciences or Medical Health, or equivalent industry experience/qualifications.
• Experience in document management.
• Experience in electronic trial master file (eTMF).
• Knowledge in clinical research and in conduct of clinical trials.
• Knowledge of ICH GCP, EU CTR, MDR, FDA, etc.
• Knowledge of GDP.
• Experience in the preparation of and processing of documents for clinical trials.
• Ability to support clinical trials.
• Strong Microsoft Office skills.