Perform monitoring and site management work to ensure sites conduct the study(ies) and report study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
Perform site monitoring visits (selection, initiation, monitoring and close‑out visits) in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol an...