• Support site start-up activities, including creation of study templates, CRFs, study manuals, site shipments, investigator binders and investigational device accountability. • Support data entry, query tracking, and remote and on-site monitoring needs in collaboration with CRO and internal team members. • Support or lead IRB submissions. • Maintain essential documents in the Trial Master File (TMF) per regulatory and company standards. • Coordinate clinical trial logistics such as meeting scheduling, site communications, and shipping of study materials. • Collaborate with CRO, central reading centers and other vendors as needed. • Draft and distribute study-related communications, agendas, and minutes. • Ensure adherence to GCP, ISO 14155, and regulatory guidelines with supervision. • Assist in the preparation of clinical study reports, presentations, and regulatory submissions. • Contribute to the development of SOPs, templates, and internal workflows.