Research Governance Coordinator

An opportunity has arisen for an enthusiastic motivated Research Governance Coordinator to support and promote research studies

2 year Fixed Term (3 days a week)

This is a two-year fixed-term, with the postholder working three full days per week in Research and Innovation. Please note if you are internal this will be for a secondment.

The Royal Berkshire NHS Foundation Trust is involved in numerous studies adopted onto the NIHR portfolio as well as studies initiated and conducted by our own staff (investigator led). All studies are coordinated at department level but overseen by the Research and Innovation Office.

The number of studies within the Trust is increasing and we need someone who can engage with investigators, offer help, ongoing support, training and education to a number of departments across the organisation. Some departments include Trauma and Orthopedics, Cancer, Ophthalmology, Renal, Emergency Department, ICU & Paediatrics/ Maternity, to name just a few.

The primary duty of the post holder will be to work with the Governance team supporting studies. We are looking for individuals who have experience in a range of areas such as: applying to Regulatory Authorities working within Information/ Research Governance policies and ensuring studies have all relevant approvals.

In addition, you will play a key role in the performance, co-ordination and working alongside clinical teams in the set up of research studies. Attention to detail and the ability to work both as part of a team and autonomously are essential requirements for this role.

PRINCIPAL RESPONSIBILITIES

• To plan and coordinate your day-to-day work in collaboration with Senior Clinical Research Facilitator.
• To be responsible for robust and accurate data systems of research studies.
• Input to governance strategies. Support and assist in the development of action plans as required.
• To provide data and analysis that aids efficient governance management of studies.
• To provide advice and training to clinical and non-clinical Trust staff relating to clinical governance protocols, governance follow up requirements and data quality and collection.
• Liaise with the appropriate research teams in assisting with Local Information Packs, as required.
• Participate, liaise, and arrange multidisciplinary meetings across the Trust, including representatives of Trials Centres, the Research Network Coordinator, Clinical Research Associates and the Medical and Nursing Teams, as required.
• Contribute to R&I strategy in growing our research portfolio.
• Ability to proficiently enter data onto the departmental or research management databases
• Delegate and refer to other research team members when risks and needs are beyond own competence and scope of practice.
• Ensure effective communications between trial centres, sponsors and investigator sites nationally and internationally.
• Perform validation checks for inconsistencies and unclear or missing data prior to data entry and raise, track and resolve queries.
• Support the updates of R&I Intranet sites.
• Ensure that all data is handled according to the Data Protection Act / GDPR and in a confidential manner, anonymising where necessary.
• Take part in reflection and appropriate learning from practice, in order to maintain and develop competence and performance.
• Provide accurate and timely information, education and support to research staff.
• Have an understanding of adverse event reporting and recording, and ensure that clinical teams, Principal Investigators and Study Co-ordinators are aware of processes to follow.
• Act at all times in a way that maintains the Trust CARE values.
• Refer to other specialists as required in order to provide optimal governance reviews.
• To liaise with relevant Clinicians / research teams to ensure timely completion of annual progress reports and end of study reports.
• Undertake study procedures required and in line with the Research Governance Framework.
• Keep up to date and implement principles of Good Clinical Practice for trials, and ensure research governance is demonstrated throughout all practice.
• To manage a caseload of research governance projects.
• To work in…