Site Management Associate I
Current-Performs onsite visits as needed to ensure sponsor and investigator obligations are being met and are compliant with applicable regulatory requirements and guidelines.-Provides training and mentoring to other team members.-Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.-Completes essential document collection and review throughout the study lifecycle, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable clinical systems according to procedures and guidelines.-Ensures timely and complete data entry by site.-Performs data review inclusive of site level data review, query resolution, facilitates database closure and freezing procedures as per study plans. -Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.-Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
