Venture healthcare company
• Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
• Primary point of contact of trial sites with regards to the conduct of the study/ project
• Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
• Ensure that the sites are adequately trained on the protocol and other study specific requirements
• Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
• Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
• Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
• Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
• Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
• Track site budget and payments
• May be involved in preparation of status reports for clients
• Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
• Act as mentor/coach to more junior staff as necessary
• Travel as necessary according to project needs
• Perform other duties as assigned by line manager