The Study Coordinator, sometimes referred to as the clinical trial coordinator, is one of the key roles in an investigator-initiated trial. Responsibilities of this position depend on whether the Study Coordinator is a member of the site clinical trial team, the Sponsor-Investigator's central coordinating team, or the coordinating lead site for an externally sponsored trial.
Responsibilities as a member of the site clinical trial team
As a member of the site clinical trial team, the Study Coordinator liaises between the Principal Investigator and Site-Specific Assessment Office and works collaboratively with the governing body, clinical and non-clinical managers, clinicians, patients, trial participants, consumers and sponsors.
The Study Coordinator works with the site Principal Investigator in the following aspects of trial planning:
- Completing site feasibility assessment, including questionnaires and participating in pre-selection visits from Sponsor
- Preparing ethics application and responding to questions, if undertaking a single site ethics application. Alternatively providing documents and information to the lead site preparing the ethics review application, if a multi-site trial with single ethics review, see Ethics and Governance Application Process
- Preparing site-specific assessment application, including seeking approval from supporting departments and submitting to the Site-Specific Assessment Officer, see Ethics and Governance Application Process
- Preparing the trial budget, in association with the business manager or similar individual within the health service organisation or trial site
- Disclosing actual or potential conflicts of interest
- Liaising with the Principal Investigator and Sponsor regarding the management, monitoring and financial requirements of the clinical trial
- Relay information between the Human Research Ethics Committee (HREC), Research Governance Office (RGO) and the Principal Investigator, including outcome of ethical and site-specific assessment review
The Study Coordinator works with the site Principal Investigator in the following aspects of trial conduct:
- Communicate the outcome of the ethical review to the Principal Investigator
- Prepare a budget for the conduct of the project in association with the business manager or similar individual within the health service organisation or trial site
- Submit the SSA form for institutional approval
- Undertaking participant screening and recruitment activities, see Recruitment and Consent
- Maintaining trial participants on the clinical trial and, where specified in the protocol, deliver or facilitate the delivery of the trial intervention
- Conducting clinical trials in accordance with skills and experience relating to the conduct of clinical trials
- Ensuring clinical trial practices reflect current professional (ethical and legal) standards for clinical trials, including reporting conflicts of interest
- Ensuring compliance with the trial approved protocol and conditions of ethics approval
- Collecting trial data and entering into the Case Report Form or trial database in a timely manner and in accordance with the trial-specific procedure, see Data Collection
- Ensuring compliance with the NHMRC: National Statement on Ethical Conduct in Human Research, legislative and policy requirements for patient contact, consent, and confidentiality of patient information
- Conducting clinical trial in accordance with national guidelines and jurisdictional health clinical trial policy and procedures
- Maintaining essential documents in the trial Investigator Site File (ISF) and making records available for review
- Responding promptly to reporting and monitoring standards, including adverse events, see Safety Reporting, complaints and clinical incidents
- Submitting annual and final reports to the local Research Governance Office and approving HREC (if applicable) in a timely manner, see Trial Progress Reporting
- Submitting notification of early project termination to the local Research Governance Office and approving HREC (if applicable)
Retain and store clinical trial data, see Data Storage and Retention, securely and for a period of time as required by national and jurisdictional legislation and the trial Sponsor.
See Sponsor-Investigator Team to understand additional Site Coordinator responsibilities required to manage an investigator-initiated trial.