Detailed job description and main responsibilities

Research management and project set up

• Provide and receive complex and sensitive research information. This requires judging a range of factors or situations and comparison of a range of options depending on the level of each research project, in order to meet the requirements of the Research Governance management and processes.
• Work closely with the Health Research Authority and Health and Care Research Wales in granting local confirmation for projects to commence. Assess individual submissions based on complex components (type of research, regulatory requirements) and decide, comparing a range of options, the appropriate course of action for approval.
• Be responsible for specific pre-delivery checks for each study registered.
• Work closely with Research Administrators and other research team members to adapt and improve the local research set up processes.
• Instigate the production of research passports for researchers who are not NHS employees and keep track of progress. Record all research passports and subsequently issued honorary research contracts or letters of access as appropriate, linking to the appropriate research master files.
• Provide support to Principal Investigators in setting up appropriate research management systems that comply with the UK Policy Framework for Health and Social Care Research at the outset of the research process.
• Lead on the input of local study specific information on Local Project management system. Ensure the quality of research database information.

Audit and monitoring

• Ensure that research projects are reviewed, audited and monitored on a timely basis and obtain the regulatory approvals as defined by policies, protocols and procedures. This requires working with a range of routine and non-routine procedures and practices to ensure that all regulatory approvals have been sought and obtained for each project active in BCUHB which are being managed from the Research office.
• Undertake appropriate auditing and monitoring activities as required as part of the Research Quality System to ensure the standards required for all research projects are carried out in line with their research proposal as agreed by approving body and are in line with Research Governance for Health and Social Care, for the duration of the life of each project.
• Audit active research projects within the Health Board in line with the requirements of the Health Board research monitoring/risk procedures. Ensure data resulting from research audits is entered onto the research management database and prepare reports summarising the findings. Follow up audit findings and ensure recommended actions are implemented.
• Promote the development and implementation of Health research Policies, Standard Operating Procedures and Guidelines within BCUHB against which research practice is assessed and monitored to ensure co-ordination of Research Governance with other initiatives of BCUHB and its partners.
• Support and give advice to researchers of varying levels of seniority both internal and external to the Health Board to fulfil Health Board Health research policies and standard operating procedures with regard to undertaking research.
• Co-ordinate, implement and maintain audit schedules/programmes, as managed by the Research Manager. This includes a rolling programme of audits of research management related systems  and support departments to ensure compliance and effective handling of research related issues, and conduct comprehensive assessments of research practice, based on the standards developed and regulatory framework (EU/UK Law). Gathering, analysing, interpreting and presenting the data and information resulting from the audits.
• Plan and organise complex programmes of monitoring studies progress and final reports, record the data obtained from reports and disseminate information appropriately.
• Provide assistance, support and advice to BCUHB own account research projects (collate data, data input, assist with randomisation procedures, produce and revise documentation content, with guidance from Research manager for specific projects)

Archiving

·         Maintains oversight for the archiving of all documents relating to all Sponsored and Hosted studies within the Health Board.

·         Follows local Standard Operating Procedures for preparing, storing and accessing materials to be archived.

·         Administers the Iron Mountain Connect system, granting access to the site, retrieving boxes, return of boxes to iron mountain, paying invoices and monitoring spend on account, carrying out audits of the site as well as annual box audits.  Arranging return and destruction of studies when required following the Health Board policy for disposal of confidential waste.

Training

• Identify training needs amongst Health board researchers.
• Provide general Research information advice and guidance to researchers from BCUHB and University, (including patient and public representatives, service users, Doctors in training and of all grades), on the research governance processes. Disseminate this information and update ensuring all new developments in Research are communicated and placed on the BCUHB website.
• Produce presentations for training purposes for researchers of all grades.

          Regularly provide Good Clinical Practice training and practical training and advice to         researchers.