Job summary
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.
Main duties of the job
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.
About us
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.
Job description
Job responsibilities
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.
- Maintain accurate documentation.
- 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 accordance with RBFT and Departmental policies and procedures.
- Promote research across the department/ Trust in relation to clinical trials.
- Assist in the education and support of all service users.
- Continue your own personal and professional development, keeping updated with current practice.
- Contribute to performance development review processes.
- Proactively seek opportunities for personal development and progression.
- To work with all members of the research team and relevant healthcare professionals to provide confirmation of capacity and capability for research studies;.This will involve appropriate understanding of the studies and trial documentation.
- To enter data onto the appropriate databases in relation to research governance studies.
- Work according to GCP and research governance standards for all aspects of work practice.
- Coordinate commercial studies under the supervision and support of senior colleagues.
- Adhere to research governance protocols and report deviations to senior team.
- Have an awareness of legislation and the Mental Capacity Act.;
- Register studies onto Siteline.
- Assist in the identification of eligible clinical studies for the Trust.
- Ensure that reports are accurately completed, in paper and electronic format.
- Communicate effectively with the study teams and other stakeholders.
- Keep up to date with departmental, Trust, NHS, and other developments for the management of clinical research.
- Provide support for colleagues in their absence.
Job description
Job responsibilities
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.
- Maintain accurate documentation.
- 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 accordance with RBFT and Departmental policies and procedures.
- Promote research across the department/ Trust in relation to clinical trials.
- Assist in the education and support of all service users.
- Continue your own personal and professional development, keeping updated with current practice.
- Contribute to performance development review processes.
- Proactively seek opportunities for personal development and progression.
- To work with all members of the research team and relevant healthcare professionals to provide confirmation of capacity and capability for research studies;.This will involve appropriate understanding of the studies and trial documentation.
- To enter data onto the appropriate databases in relation to research governance studies.
- Work according to GCP and research governance standards for all aspects of work practice.
- Coordinate commercial studies under the supervision and support of senior colleagues.
- Adhere to research governance protocols and report deviations to senior team.
- Have an awareness of legislation and the Mental Capacity Act.;
- Register studies onto Siteline.
- Assist in the identification of eligible clinical studies for the Trust.
- Ensure that reports are accurately completed, in paper and electronic format.
- Communicate effectively with the study teams and other stakeholders.
- Keep up to date with departmental, Trust, NHS, and other developments for the management of clinical research.
- Provide support for colleagues in their absence.
Person Specification
Education, Qualifications and Training
Essential
- NVQ level 4 or equivalent knowledge and skills gained through any combination of alternative study, employment or voluntary work with passes at GCSE grade 4/ C or above in English and Maths.
- European Computer Driving License or equivalent skills in IT literacy e.g excel, powerpoint and email.
- Willing to undertake further education.
Desirable
- RSA Typing Level 2 - 3
- Educated to Degree level / or equivalent professional qualification
- Good Clinical Practice and EU Directive Training
Experience
Essential
- Previous experience of working in a healthcare setting.
- Proven experience of working within a team.
- Previous experience of administration or clerical work
- Previous experience of working to tight deadlines under pressure
Desirable
- Experience of Research Governance.
- Experience in delivering presentations to groups
- Working knowledge of NHS information systems.
- Experience of clinical audit
- Understanding of research trials and processes.
Skills
Essential
- Proven experience of a logical and organised approach to work
- Proven ability to work on own initiative
- Analytical & an aptitude for highly detailed, accurate work
Desirable
- Skills in report writing, succinct discussion and ability to produce documents/ reports and correspondence
- Time management skills
- Ability to manage projects with minimal supervision
Person Specification
Education, Qualifications and Training
Essential
- NVQ level 4 or equivalent knowledge and skills gained through any combination of alternative study, employment or voluntary work with passes at GCSE grade 4/ C or above in English and Maths.
- European Computer Driving License or equivalent skills in IT literacy e.g excel, powerpoint and email.
- Willing to undertake further education.
Desirable
- RSA Typing Level 2 - 3
- Educated to Degree level / or equivalent professional qualification
- Good Clinical Practice and EU Directive Training
Experience
Essential
- Previous experience of working in a healthcare setting.
- Proven experience of working within a team.
- Previous experience of administration or clerical work
- Previous experience of working to tight deadlines under pressure
Desirable
- Experience of Research Governance.
- Experience in delivering presentations to groups
- Working knowledge of NHS information systems.
- Experience of clinical audit
- Understanding of research trials and processes.
Skills
Essential
- Proven experience of a logical and organised approach to work
- Proven ability to work on own initiative
- Analytical & an aptitude for highly detailed, accurate work
Desirable
- Skills in report writing, succinct discussion and ability to produce documents/ reports and correspondence
- Time management skills
- Ability to manage projects with minimal supervision
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
