• Assist CTMs with activities related to study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment.
• Assist with tracking, reviewing, distribution, and storage of key internal and external documents such as investigator brochures, protocols, interim safety reports, and site/subject material, through the course of the study.

• Maintains and disseminate basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor metrics, and Enrollment metrics.
• Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met and study documents are delivered to the Sponsor in a timely manner.
• Track study wide clinical supply inventory, vendor supplies at sites and management of study samples.

• Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out and responding to TMF related inquiries.
• Maintains and ensures all documentation is in a state of audit-readiness.
• Utilise project management tools (e.g. Outlook, Word, PowerPoint, Timelines, Excel) in order to plan and execute effective meetings with appropriate materials and balance scope and schedule for each trial.
• Support clinical team efforts to track and contribute to regulatory submissions in the US and globally by coordinating and tracking approvals of clinical documents.
• Ensure GCPs are followed, protocol deviations are properly recorded, SOPs are maintained and routinely updated, and CRO/site audits are tracked.
• Coordinate collection, tracking, and maintenance of updated site regulatory documentation (i.e. FDFs, 1572s, CVs, IRB approvals, etc.).
• Develop working knowledge of company standard operating procedures (SOPs) and familiarity with FDA and global regulations related to clinical studies.
• Help investigator meetings including venue selection, invitations, agenda, and materials distribution.