Start your clinical research career and unterstand the role and responsibilities of a Trial Master File Specialist during Clinical Trials. Take on roles responsible for managing the Trial Master File, which is the collection of all essential documents related to a clinical trial.
Gain a comprehensive understanding of the structure, purpose, and regulatory requirements of the TMF, ensuring accuracy and compliance in clinical trials.
Learn the importance of thorough documentation within clinical trials and the key responsibilities of a TMF Specialist in maintaining complete and accurate records throughout all study phases.
Understand the guidelines and standards, including ICH-GCP, that govern TMF management and how to effectively apply these in real-world scenarios to support trial integrity and regulatory compliance.
Acquire the skills to prepare and maintain the TMF for regulatory inspections and audits, ensuring that your documentation supports the reliability and credibility of trial data.
This module equips you with the fundamental knowledge and practical skills needed to excel as a TMF Manager in clinical trials. You will delve into the critical aspects of documentation management, understand the structure and content of a TMF, and learn the primary responsibilities of a TMF Manager across various study phases. By the end of this module, you’ll be adept at ensuring accuracy and completeness in clinical trial documentation, which is crucial for regulatory compliance and successful trial outcomes.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the purpose of a Trial Master File (TMF) and its significance in clinical trials.
✓ Learn about the different TMF formats and how to manage them effectively.
✓ Explore the main tasks and responsibilities of a TMF Manager during different study phases.
✓ Gain insights into the importance of accuracy and completeness in maintaining a TMF.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
This module will equip you with a comprehensive understanding of the Trial Master File (TMF) structure, an essential component in clinical research. You’ll delve into the detailed aspects of the TMF, ensuring you can maintain accuracy and completeness in all your documentation efforts.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Explain the detailed structure of a TMF
✓ Describe the different TMF zones and their functions
✓ Outline the Reference Model as the “gold standard”
✓ Understand the importance of accuracy and completeness in a TMF
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
Dive deep into the critical aspects of maintaining a Trial Master File (TMF) with this comprehensive module. You’ll gain a thorough understanding of the regulatory requirements and best practices for setting up, maintaining, and archiving TMFs, ensuring your clinical trials are managed efficiently and comply with all necessary guidelines.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the purpose and key pillars of a TMF.
✓ Gain familiarity with regulatory requirements and guidelines related to TMFs.
✓ Learn the role of the TMF in trial management and inspection.
✓ Understand the requirements for archiving and retaining TMF documents after the trial.
✓ Know how to set up and organize a TMF.
✓ Ensure the completeness and accuracy of documents in the TMF.
✓ Maintain ongoing TMF maintenance throughout the trial.
✓ Prepare and present a final TMF report to stakeholders.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
In this module, you’ll gain a comprehensive understanding of the importance of meticulous documentation within a clinical trial. By exploring the structure and content of both the Investigator Site File (ISF) and the Pharmacy Site File (PSF), you will learn how to ensure accuracy and completeness in clinical research documentation.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the critical importance of documentation in clinical trials.
✓ Explore the detailed structure of an ISF and a PSF.
✓ Learn the best practices for maintaining accuracy and completeness.
✓ Gain insights from experts in the field.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.
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Becoming a Trial Master File (TMF) Specialist can be a rewarding career path for individuals who have a strong attention to detail and organizational skills, as well as an interest in clinical research. Here are some reasons why you may want to consider becoming a TMF Specialist:
In summary, becoming a TMF Specialist can offer a challenging and rewarding career path for individuals who are interested in clinical research and have strong organizational skills. The role offers job security, growth opportunities, and the ability to make a meaningful contribution to medical research.
The responsibilities of a Trial Master File (TMF) Specialist can vary depending on the organization they work for and the specific clinical trials they are involved in. However, here are some typical responsibilities that a TMF Specialist may have:
Overall, the TMF Specialist plays a critical role in ensuring that clinical trials are conducted in accordance with regulatory requirements and industry best practices, by managing and maintaining the essential documents related to the trial.
Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:
We also show you how to best share your certificate on LinkedIn and other social media platforms.
There are several reasons why you might consider getting a CRA certification:
Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.
Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.
Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.
Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.
Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.
No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).
To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.
In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.
If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at academy@viares.com and we will contact you.
Trial Master File Specialist
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Verified ownerIt has been apleasure
Verified ownerJust finished the VIARES CRA Academy and I’m blown away. Clear, practical, straight-to-the-point lessons that actually prepare you for the real job. Passed the exam first try. Best investment I’ve made in my career. Highly recommend!
Thank you VIARES
Verified ownerReally good work and presentations. I wish live also be a part of it. Otherwise the course is excellent
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