Facing TMF Bias: My Role is Not Entry Level PART TWO
Part Two: I tenaciously strive for TMF success. I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. This need not be the reality. There is no revolving door where I work. My team has left…
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Facing TMF Bias: My Role is Not Entry Level PART ONE
I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. By the time they are proficient, they leave to embrace a new specialty. This need not be the reality. There is no revolving door where I…
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The Importance of a Single Document
While working within a Trial Master File (TMF), it can often seem like there is no end to the number of documents needed for a clinical research study. There are multiple documents for different aspects of a study – from trial management to site management, safety, statistics, data management and everything in between. But one…
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Where Should I Begin?
Experience in various roles within clinical research greatly helps with having an understanding of the Trial Master File (TMF) but it’s not always necessary to have decades of experience in clinical research to be an effective TMF Analyst or Auditor. The most important thing to keep in mind when performing a TMF Quality Control (QC)…
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