START Dublin Early Phase Clinical Trials Unit
Recent years have seen astonishing and rapid advances in the understanding and treatment of cancer. Technological innovations have resulted in more rational drug design, bringing hope of better treatments to patients who have been diagnosed with advanced cancer but who may have stopped benefitting from traditional treatments such as chemotherapy. For Irish patients, it is difficult however to gain access to the cutting edge of drug development and accessing new drugs is a serious issue for patients and doctors in this country. To address this, the Mater hospital is partnering with The START Centre for Cancer Research, a physician-run clinical trials group and one of the global leaders in early phase oncology trials. Early phase (or Phase 1) trials are where new and exciting drugs are first evaluated in patients for evaluation of safety and the first signs of efficacy. START Dublin is Ireland’s first and only phase 1 clinical trial site and is physically located at and operated by The Mater Hospital. This exciting venture will meet a national need, giving our patients the opportunity to access exciting and innovative drugs that they would not otherwise be able to access in the context of a well-run and closely monitored program.
Purpose of the Role
The START Dublin Data and Regulatory Affairs Manager will be responsible for all aspects of the management of data for studies, including timely filing in the investigational site file (ISF) system, transcribing accurate data from clinical notes into Case Report Forms (CRF) (electronic or paper as required) in accordance with the trials protocol, meeting sponsor deadlines, and pro-actively communicating with sponsors to facilitate protocol review and study activation activities, and ensuring efficient running of clinical trials. They are also required to support a number of administrative duties which relate directly to the study activation, data capture, and management of clinical trials, as well as liaising with sponsors and upholding GDPR regulations including ICH GCP Regulations and EU Clinical Trial Directive Regulations. The START Dublin Data and Regulatory Affairs Manager will also have responsibility for liaising with regulatory bodies, the Clinical Trial Information System (CTIS) as per EU Directive, and ensuring that all trials are in line with Irish and EU legislation.
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