Detailed job description and main responsibilities

·        To support the set-up and delivery of the study within the Trust. 

·        To develop effective contacts with relevant stakeholders.

·        To ensure service users are provided with written information relevant to the study and are given the opportunity to discuss the research or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate.

·        To recruit and consent service users into the trial.

·        To administer standardised outcome measures and extract data from patient notes for quantitative analysis.

·        To maintain accurate service user trial documentation, complete Case Report Forms, including the use of electronic data capture systems and ensure relevant information is recorded in service users’ medical notes.

·        To coordinate all study activities in accordance with the research protocol.

·        To attend and support service users in the clinical environment for monitoring, assessment and follow up as part of the research project. This includes carrying out screening, recruitment, and assessment of patients for the purposes of research.

·        To record and report any Adverse Events and Serious Adverse Events according to trial protocol and local procedures.

·        To provide information/reports on recruitment as requested by the Principal Investigator and the central study management team.

·        To make regular contact with clinicians supporting the trial to increase recruitment.

·        To work at all times according to International Conference on Harmonisation Good Clinical Practice Guideline (ICH GCP).

·        To ensure that any data collection and information governance is conducted according to specific research protocols (in liaison with the research teams) and adheres to the Data Protection Act 2018 and according to Good Clinical Practice guidelines.

·        To maintain the highest standards of record keeping and report writing.

·        To prepare test materials and visual aids as required.

·        To liaise with service users and clinical staff in order to provide them with an understanding of clinical research ethics in practice.