Detailed job description and main responsibilities

Please see Job Description:

·         Be responsible for the delivery of allocated research studies.

·         Ensure that the delivery of studies meet requirements with regards to the All Wales Research Governance Framework for Health & Social Care and the EU Clinical Trials Directive by implementing quality systems.

·         Participate in Good Clinical Practice (GCP) training.

·         Contribute to the Expression of Interest / Study Selection process

·         Contribute to study set up, recruitment planning and study delivery.

·         Be responsible for promoting the appropriate referral and recruitment of patients to clinical research studies. Work with research teams and investigators to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies.

·         Coordinate and run study visits including off site visits whilst adhering to the lone worker policy.

·         Work with other departments within the UHB to ensure that trial specific investigations and procedures are undertaken as required by the trial protocol, in order to establish eligibility and safety of patients within research.

·         Contribute to the accurate costing for research studies and appropriate negotiation of required financial support to deliver studies.

·         Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.

·         Ensure that data is transcribed accurately where required and assist with the maintenance of the Trial Master File.

·         Respond to data queries generated by the study coordinating team within a timely manner.

·         Ensure the recording & reporting of adverse and serious adverse events that occur whilst the participant is in the research study to the study co-coordinator/Principal Investigator (PI) and R&D office in line with the study protocol, local policies and regulatory requirements.

·         Assess and evaluate the progress of on-going studies, maintaining accurate records of the status of studies and providing regular updates to the department on the status of the studies. This will involve ensuring that the Local Patient Management System (LPMS) is updated with key study data and validated efficiently.

·         Escalate on-going study performance issues to the Senior Research Nurse/Team Lead.

·         Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D, sponsors, study monitors and external bodies.

·         Assist in study close down and the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.