Unblinded Studies
One of the more enigmatic areas within PPD is known as “Unblinded Studies.” But once you realize the critical nature of our work, its importance becomes crystal clear. When there is an aspect of the study drug that is not blinded from all individuals involved in the conduct of the study, it is crucial that a knowledgeable and experienced team manage the unblinded parts of that study. Your job will be to monitor IP-related activities at an investigator site when the IP is not available in a blinded manner. You will ensure that all risks of potential unblinding are shared with the study teams on an ongoing basis—and that the integrity of these trials remains secure.
best-fit characteristics
If you’re wondering whether you’re a good candidate for this area, we seek CRAs who want to enjoy the autonomy of a critical role within a contained scope of work, as well as an increasing level of independence. You’ll have a good chance to succeed here if you have the confidence in your abilities and knowledge to hold your position, as managing unblinding can require a firm approach to ensure full compliance.
Your attributes and experience
Unblinded Studies is a unique and engaging area where CRAs can acquire important career skills and build meaningful experience. In addition to experience as a CRA, you’ll need to complete the Unblinded Training sessions included on the PPD SharePoint site here.
Skills you can attain here
Within Unblinded Studies, you’ll have the opportunity to gain valuable experience overseeing the progress of a blinded study at an investigator site. This includes verifying that the unblinding procedure(s) are conducted, recorded, and reported in accordance with the protocol, SOPs/WPDs, ICH GCP, Unblinding Monitoring Plan, and applicable regulations.