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Clinical Research Tmf Documentation Associate Jobs in District of Columbia

Clinical Document Management Associate (Tmf /Oncology) - 1 Year Contract – Hybrid- Nc Pharma
By Frankel Staffing Partners At Raleigh-Durham-Chapel Hill Area, United States
Support the management of eTMF documentation issues throughout the lifecycle of a study
Proactive management of clinical documentation and trackers
Experience working with documents at study start-up, during study conduct and close-out will be required
Experience in handling TMF documents during a regulatory inspection will be a plus.
Proactive and smart organizational skills
Excellent documentation skills and detail-orientation

Are you looking for an exciting opportunity to join a dynamic team of Clinical Research TMF Documentation Associates? We are looking for a highly motivated individual to join our team and help us ensure the accuracy and completeness of our clinical trial documentation. You will be responsible for reviewing and maintaining clinical trial documents in accordance with regulatory requirements and company standards. If you have a keen eye for detail and a passion for clinical research, this could be the perfect job for you!

Overview Clinical Research Tmf Documentation Associate is responsible for managing and maintaining the Trial Master File (TMF) for clinical studies. This includes ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines. The Clinical Research Tmf Documentation Associate is also responsible for providing support to the clinical team in the preparation and submission of documents to regulatory authorities. Detailed Job Description The Clinical Research Tmf Documentation Associate is responsible for managing and maintaining the Trial Master File (TMF) for clinical studies. This includes ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines. The Clinical Research Tmf Documentation Associate is also responsible for providing support to the clinical team in the preparation and submission of documents to regulatory authorities.

The Clinical Research Tmf Documentation Associate will be responsible for:

• Ensuring that all documents are properly filed, indexed, and tracked in accordance with applicable regulations and guidelines.
• Assisting with the preparation and submission of documents to regulatory authorities.
• Maintaining the TMF in accordance with applicable regulations and guidelines.
• Ensuring that all documents are properly stored and archived.
• Providing support to the clinical team in the preparation and submission of documents to regulatory authorities.
• Assisting with the development and implementation of TMF processes and procedures.
• Assisting with the development and implementation of quality assurance processes and procedures.
• Assisting with the development and implementation of audit processes and procedures.
• Assisting with the development and implementation of training processes and procedures.
• Assisting with the development and implementation of document control processes and procedures.
• Assisting with the development and implementation of document management systems.
• Assisting with the development and implementation of document retention policies.
• Assisting with the development and implementation of document archiving processes and procedures.
• Assisting with the development and implementation of document security processes and procedures.
• Assisting with the development and implementation of document destruction processes and procedures.
• Assisting with the development and implementation of document tracking processes and procedures.
• Assisting with the development and implementation of document review processes and procedures.
• Assisting with the development and implementation of document version control processes and procedures.
• Assisting with the development and implementation