Key Responsibilities:
- Support clinical study coordination, including study tracking (e.g. dashboards, Gantt timelines, milestones, start-up and close-out activities) and status updates.
- Maintain and manage Trial Master File (TMF) and Sponsor Oversight Documentation System (SODS), ensuring accurate documentation and recordkeeping.
- Coordinate document workflows, including tracking, approvals, and signatures for CDAs/NDAs, contracts, insurance, payments, and other study-related documents.
- Maintain clinical study team lists and support internal / external communication and meeting logistics, including agendas and minutes.
- Ensure timely updates of clinical study information in registries (e.g. ClinicalTrials.gov).
- Prepare and coordinate study materials, including investigator meeting content and training materials for internal and external stakeholders.
- Support clinical trial execution across study phases (start-up, enrollment, maintenance, closure), incl. site support, issue tracking, payments, and archiving activities.
- Assist with cross-functional coordination, study supplies management, and general clinical development operations as needed.
- Provide administrative support to the Clinical Operations leadership, and manage meeting logistics, team events and travel arrangements, if needed.
- Support functionally by conducting researches and creating materials, as well as taking ownership for certain Clinical Operations processes (e.g. clinical trial insurances, compliant archiving).