Sponsor-Investigator Team
The responsibilities of the Study Coordinator (or Research Nurse) are similar whether they are a member of the Sponsor Investigator’s central trial coordinating team or the coordinating lead site. In the latter, the responsibilities may be less as the trial Sponsor will retain some oversight responsibilities, particularly in multinational trials where there may be several coordinating lead sites across different geographical regions.
As a member of either team, the Study Coordinator supports, facilitates and coordinates the responsibilities of the Sponsor-investigator or Sponsor in the planning and conduct of an investigator-initiated trial. It is essentially a project manager role and for larger trials, this position may be referred to as the Trial Manager or Lead Trial Coordinator.
The Study Coordinator in either case liaises between the Sponsor-Investigator or Sponsor and the following parties:
The Study Coordinator also works with site Principal Investigators in the following aspects of trial planning:
- Facilitating completion of site feasibility assessments, and any follow up pre-selection visits
- Preparing ethics applications and responding to questions, see Ethics and Governance Application Process
- Preparing the central trial budget, with input from participating sites
- Disclosing actual or potential conflicts of interest
- Liaising with the site Principal Investigator and Sponsor-Investigator or CPI regarding the management, monitoring and financial requirements of the clinical trial
- Relay information between the HREC and the site Principal Investigator, including outcome of ethical review
- Developing resources to appropriately train the site clinical trial team in protocol requirements and adherence to trial procedures, see During Ethics and Governance Review
- Assisting site Principal Investigators in overseas locations to prepare any applicable regulatory submissions
- Arranging delivery of investigational product to a participating site once all approvals are in place, including ethics approval, local site authorisation, and any applicable regulatory approvals, eg Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) and the site initiation meeting has taken place, see Trial Conduct
- Ensuring the clinical trial is registered on a publicly accessible clinical trial registry, prior to the recruitment of the first trial participant, see During Ethics and Governance Review
The Study Coordinator works with site Principal Investigators in the following aspects of trial conduct:
- Arranging timely patient payments to participating sites in accordance with agreed terms in contractual agreements
- Regularly monitoring trial conduct, see Monitoring Trial Conduct
- Keeping the sites informed of any changes to the risk profile of the trial as new information becomes available during the trial and subsequent changes to the trial protocol and associated documents, eg Reference Safety Information (RSI)
The Study Coordinator role within the central coordinating team is also the key person responsible for managing essential documents in the Trial Master File (TMF) and associated Site Information Files (SIFs). This should be done in accordance with the sponsoring institution’s SOP for managing essential documents.