Available Services

• Liaise and act as a communication link on behalf of the site, with sponsors and their representatives to provide all relevant documentation for ethical and regulatory governance submissions.
• Efficiently prepare and co-ordinate all documentation required to gain Human Research Ethics Committee (HREC) and Research Governance Office (RGO) approval for the clinical trials.
• Address all and any queries raised from HREC and RGO to gain approvals.
• Identify and proactively address potential delays to clinical trials submissions.
• Work within the forecasted submission/approval timelines and ensure they are complied with.

If Budget negotiations are involved with the Study Start-Up Application, primary responsibilities will include the above as well as:
• Assist in negotiations of budget and contract with sponsors and their representatives.
• Assist in producing site specific contracts.
• Assist with arranging the execution of contracts on behalf of the site.
• Raise invoices to sponsor.

This involves tracking the study budgets over the lifetime of the trial and making sure that all visits and invoiceable items are covered/reimbursed. A detailed excel spreadsheet will be used to track the visits and procedures performed and will be provided to the team monthly unless a shared platform is preferred by the study team for live updates.

This involves medical record and research source documentation verification against case report form (eCRF) data, including informing the site staff of any entry errors and ensuring good documentation practices are being adhered to. This will require access given to Nasta Specialists Pty. Ltd. to the data source notes (i.e., site medical files) and the portal used for sponsor verification of data.
Data will be reviewed throughout the month of patient visits.