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Clinical Research Tmf Documentation Associate Jobs in Illinois

Consulting Associate - Healthcare, Clinical Documentation
By Huron Consulting Group Inc. At , Chicago, 60631, Il
Direct supervisory experience including coaching, mentorship, and performance management
3 to 5 years relevant project implementation or process improvement experience in a team-based environment, preferably within healthcare or consulting
Willingness and ability to travel every week (Monday-Thursday with occasional onsite Fridays) and work extended hours as needed
Proficient in Microsoft office (Word, PowerPoint, Excel)
Clinical Documentation Associate Jobs
By Planet Pharma At Deerfield, IL, United States
Efficient and effective time management skills with ability to successfully manage competing priorities.
Train/mentor departmental and vendor staff on file management systems and processes.
Assist in management of internal and external assessments and corrective/preventive actions .
AA or BA/BS degree and 5 years clinical experience including organizing and coordinating Trial Master Files for clinical trials
High level of competency with Veeva eTMF and knowledge of the TMF Reference Model, supported by DIA.
Accountable for delivery of assigned TMF activities in accordance with project requirements/timelines and as outlined in the TMF Plan.
Clinical Research Associate Jobs
By Castle Biosciences, Inc. At Elk Grove Village, IL, United States
M-F; working remotely from home, Midwest USA-based location, near a major airport; travel routinely 50-60% and up to 80% at times.
Bachelor's degree in a science or healthcare-related field or a registered nursing certification or equivalent certification/licensure from an appropriately accredited institution.
3 years of CRC experience or previous 1-year experience as a CRA.
Direct patient care or clinical research experience required.
Familiarity with clinical research and study development processes.
Valid Driver's License where applicable.
Tmf Specialist / Clinical Trial Associate
By EPM Scientific At Chicago, IL, United States

3-5+ years of industry experience

In-depth knowledge of TMF process

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