Julie Stephenson

A Clinical Trials Associate/Site Management Associate II is responsible for supporting and managing clinical trial sites to ensure compliance with protocols, regulations, and company procedures. This role involves a mix of on-site and remote activities, including site initiation, monitoring, and close-out visits, as well as maintaining communication with sites and project teams.

Good knowledge of clinical research processes and an understanding of Regulatory and Central/Local ethic submission processes for assigned countries; working knowledge of current ICH GCP guidelines and applicable regulations.

Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.

Served as a key liaison between investigative sites and study sponsors, ensuring prompt communication of updates, concerns, or requests.

Managed investigational product inventory levels, ensuring adequate supply for all enrolled patients at each study location.

Maintained study-related trackers and updating system access user lists.

Assisted with the preparation, tracking, and maintenance of study documents, including the Trial Master File (TMF).

Assisted with data collection, verification, and entry into clinical trial management systems (CTMS).

Ensured compliance with regulatory guidelines, maintaining accurate and up-to-date records throughout all phases of the trial.

Collected, evaluated, and modeled collected data.

Followed informed consent processes and maintained records.