Senior Research Governance Facilitator

Job responsibilities

Analytical/Judgmental Skills

• Have a full understanding of the requirements for NIHR HRA, MHRA, NRES and research governance review procedures, including knowledge of NHS Support Funding, ICH-GCP and other related research management functions to support researchers.
• Carry out full and comprehensive Capacity and Capability Assessments for research studies that require it in a timely manner. This includes assessing that research staff are appropriately trained/qualified and that facilities are suitable for research in line with current in-house approval processes.
• Oversee R&Ds process for reviewing amendments to ongoing studies. Assessing impact to resources or facilities and any effect upon compliance with legislation, policy or guidance and provide recommendations regarding continued study participation.
• Support researchers with the process for submission of research applications through the IRAS system.
• Assess researchers requirements for access to data or patients, and recommend appropriate HR actions regarding research passports, honorary research contracts, letters of access, and pre-engagement checks, following national guidance and local policy.Review and assess research study contracts, ensuring the Trusts legal position is not compromised.
• Liaise with research study sponsor regarding study costings using appropriate guidance e.g. AcoRD. Oversee completion of industry costing templates and ensure appropriate set up of financial arrangements between funder and Trust finance dept.
• Take responsibility for own judgements when reviewing research studies.
• Provide support to research committees and groups as required by the Trusts R&D department.
• Manage appropriate RM&G advice and guidance to information requests coming into the research office, including acting as first telephone and email contact for enquiries from external researchers and research organisations.

Knowledge

• Ability to read and interpret data, legislation, regulation, guidance and standards and apply this knowledge to all aspects of research and specialisms.
• Be able to interpret complex research protocols and its impact on service. Having the ability to explain these in laymans terms.
• Pro-actively assist in facilitating potential opportunities for industry sponsored research.
• Post holder will be required to maintain a good working knowledge of legislation as it relates to research, keeping abreast of any new governmental requirements.
• Be knowledgeable about internal governance processes to ensure reportees are trained and competent to carry out their roles within R&D.
• Attend conferences and workshops related to the post as required and disseminate learning to the R&D team.

Responsibility for Information Resources

• Maintain the EDGE database and the Trusts own research projects database and ensure that the project records are kept up-to-date and accurate.
• Maintain comprehensive electronic and paper files as appropriate for individual research projects, ensuring that contractual, legal and policy requirements are complied with.
• Support the Research Manager in performing data integrity reviews and the provision of statistics and performance metrics on all aspects of research activity in the Trust.
• Be adept at building databases for use within the department as required.
• Interrogate and produce performance reports using EDGE, local databases and national information systems e.g. ODP and CPMS as requested.
• To day-to-day oversight, provide training and compile learning guides to assist staff in the understanding and use of technology software for research activities.
• Ensure that information held and produced for any party is in line with current legislation governing the use of information. (e.g. Freedom of Information Act, GDPR etc)
• Regular audit and correction of inaccurate information in accordance with Trust procedures.

Policy and Service Development

• Write departmental SOPs, policies and procedures and contribute to review of the departments policies and procedures as required by the Research Manager.
• Contribute to and update the R&D intranet and website pages as required.
• To assist in establishing and developing a clear framework to support groups of clinicians, academics and their research support teams, enabling them to manage funding applications as appropriate, including the dissemination of relevant funding calls to appropriate Trust staff.
• To identify research funding opportunities that meet the Trusts research interests and develop partnerships, for example with academia and industry to write successful grant applications.

Communication/relationship skills

• Display a professional, polite and presentable approach and timely response at all times during interactions with anyone who contacts the research office.
• Be able to clearly and professionally communicate local or national policy changes to researchers or others who may be affected.
• Communicate effectively with external agencies i.e. other R&D departments, ethics committees, Universities, commercial companies etc regarding all aspects of the application and approval process.
• Provide regular communications to clinicians, research nurses and other applicants on the progress of research submissions.
• Represent the Trust at research meetings in a professional and business-like manner, as required.
• Deal with difficult issues with researchers and R&D staff in a tactful and polite manner, maintaining a professional approach at all times.

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