- Assist CTMs with activities related to study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation, investigational product release as well as patient enrollment.
- Help 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.
- Maintain 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 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.
- Utilize 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.
- Ensures GCPs are followed, ensures 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 SOPs and familiarity with FDA and global regulations related to clinical studies.
- Participates in organizing investigator meetings including venue selection, invitations, agenda, and materials distribution.
- Communicate effectively with members of the internal team and vendor project teams.