CHaRT is structured around six senior positions: the Director Graeme MacLennan, the Research Managers Kirsty McCormack and Ruth Thomas, the Senior Trial Manager Alison McDonald, the Senior IT Development Manager Mark Forrest, the Quality Assurance Manager Samantha Wileman, and the PA/Secretary. CHaRT also comprises of a team of Trial Managers, Data-coordinators, a Senior Programmer and Programmers.
Senior CHaRT staff
The Director is responsible for the scientific and research aspects of CHaRT. The Director contributes to the design and reporting of the study, and provides experienced guidance for the conduct and management of the trial. The Director takes overall responsibility for the compliance of CHaRT’s contribution to the randomised trial to all the technical, regulatory, legal and ethical requirements and guidelines applicable (including the EU Clinical Trials Directive and Research Governance guidance).
The Research Managers
The Research Managers assist the Director in responding to requests for CHaRT to become involved in developing a proposed trial for adoption into the CHaRT trials portfolio. The Research Managers will be responsible for ensuring that CHaRT is able to make a considered judgement as to whether a proposed trial is suitable for the CHaRT portfolio of trials. This involves facilitating contact with researchers proposing a trial to allow the assessment of how fully the trial meets CHaRT's criteria for scientific engagement and, if taken forward, assisting the researcher in developing and designing a high quality proposal for submission to national peer reviewed funding competitions. Further details on developing new trials can be found here.
The Senior Trials Manager
The Senior Trials Manager ensures that required tasks in the conduct of all CHaRT trials are carried out in a timely and satisfactory manner, and documented to a standard necessary to comply with relevant guidelines (e.g. Good Clinical Practice). The Senior Trials Manager will oversee those personnel responsible for the day-to-day running of individual trials, both within and outwith HSRU. The Senior Trials Manager will site-visit the coordinating centres of trials based outside HSRU, giving advice to local investigators on issues of trial conduct and providing assurance to CHaRT and the Trial Steering Committees that study procedures are being transacted in accordance with relevant requirements, in particular those relating to trial conduct and patient safety.
The Senior IT Development manager
The Senior Information Technology (IT) Development Manager is responsible for supervising and managing all the IT aspects of CHaRT’s involvement in trials: randomisation services; database design and maintenance (both analysis databases for the scientific reporting of the study, and administrative databases, for the conduct of the study); authoring or approving applications for the smooth and efficient operation of the study (e.g. data dumps for statisticians for reports for study committees, visit schedules for participating centres, intervention re-supply schedules); and creating data entry and data query initiation / query resolution applications (either paper based or using remote data capture). The Senior IT manager will ensure that all computing systems and applications are tested and documented as being fit for purpose, and that these systems are implemented and used in a fashion compliant with all required regulation (e.g. Data Privacy and Protection).
The Quality Assurance Manager
The Quality Assurance Manager is responsible for developing robust quality assurance systems and integrating them into CHaRT's best working practices. The Quality Assurance Manager will ensure that: staff are adequately trained for their tasks, familiar with CHaRT's remit for staff training, education and development (including GCP) and working to CHaRT's Standard Operating Procedures (SOPs); and conducting assessments of quality within CHaRT's projects. The Quality Assurance Manager will also oversee CHaRT's co-operation within external auditors as well as facilitating all activity to detect, or arising from the discovery of, fraud and misconduct. Further information can be found here.
The CHaRT Secretary supports the senior staff in CHaRT. In particular, the Secretary performs a PA role for the Director, organising the Director’s appointments and managing communication. The Secretary takes care of all travel arrangements, and takes minutes at the monthly CHaRT meetings. The Secretary takes responsibility for processing enquiries flowing into the CHaRT office, all communications going out of the office, and is involved in the preparation of grant applications.