Research Governance Officer

Job overview

An exciting opportunity has arisen for a motivated and organised Research Governance Officer to join the Research and Development department at Mid Cheshire Hospitals NHS Foundation Trust (MCHFT).

This Band 5 post is an ideal entry point for someone looking to build a career in clinical research governance and regulatory compliance. Working within a supportive and growing R&D team, the post holder will play an important role in maintaining the quality, integrity, and regulatory compliance of MCHFT’s research portfolio — spanning commercial, NIHR-portfolio, and investigator-led clinical trials.

The post holder will work closely with the Research Governance Manager, clinical research nurses, and principal investigators to ensure research activities meet the standards set out in the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP), and all applicable regulatory requirements.

MCHFT is committed to expanding patient access to clinical research and building an inclusive, high-performing research culture. This role offers genuine development opportunities within a department that has clear strategic ambitions and strong senior leadership.

Main duties of the job

The Research Governance Officer is responsible for the independent coordination and oversight of the governance, regulatory compliance and administrative management of research studies conducted within the Trust. The post holder ensures full adherence to the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP), and all relevant legislation, including the Health Research Authority (HRA) framework and MHRA regulations.

Operating with a high degree of autonomy including independent decision-making on study governance pathways, compliance actions and escalation thresholds, the post holder coordinates study setup, leads internal governance audits, manages regulatory submissions, negotiates financial and contractual arrangements with external sponsors and pharmaceutical companies, and provides expert governance advice to clinical investigators and research teams. The role requires the application of specialist knowledge to interpret complex regulatory requirements, resolve governance issues, and lead service improvements across the Trust’s research portfolio.

Detailed job description and main responsibilities

Study Coordination and Operational Management

• Manage and coordinate research studies from setup to closure, taking responsibility for all governance, regulatory and operational milestones.
• Co-ordinate work within the local research administrative team, ensuring that adequate arrangements are in place and implementing contingency where required.
• Provide progress and governance reports to all relevant parties, prepare presentations on behalf of the study or research team, and participate in study and team meetings as required.
• Ensure R&D targets for study set-up are achieved within agreed timeframes; identify, escalate and resolve problems in a timely and structured manner.
• Ensure R&D KPIs (including but not limited to time to first patient recruited, recruitment to time and target) are recorded accurately and reported within required timeframes.
• To work with colleagues to maintain Trust-wide electronic information systems to track patient accruals, recruitment targets and speciality activity.

Governance, Regulatory and Compliance Responsibilities

For All Trials

• Lead the administrative and governance set-up of all research studies within MCHFT R&D, acting as the primary point of contact with pharmaceutical companies, study sponsors, Clinical Trials Units (CTUs), Clinical Research Organisations (CROs), the Trust Research Office and Research Networks.
• Negotiate contractual and financial arrangements with study sponsors, pharmaceutical companies and CROs, using persuasive negotiation skills to secure agreement on cost recovery models, invoicing schedules, resource requirements and activity-based payments within Trust financial parameters.
• Communicate complex and sensitive regulatory requirements, governance expectations, and compliance findings to clinical investigators, research leads and external stakeholders – employing negotiating and persuasive skills to ensure cooperation and corrective action within required timeframes, including in situations where investigators or sponsors may initially be resistant.
• Liaise with and advise and guide the study team in preparing and submitting applications to Research Ethics Committees, the HRA, MHRA and other regulatory bodies, ensuring all documentation meets current requirements and is submitted within agreed timescales.
• Implement and maintain procedures ensuring the team is compliant with the principles of Good Clinical Practice, the UK Policy Framework for Health and Social Care Research and all relevant regulatory legislation.
• Develop, review and implement department and/or trial-specific Standard Operating Procedures (SOPs) and Work Instructions; disseminate updated SOPs to all relevant research staff and provide training on their application, ensuring changes in national guidance are reflected in Trust practice.
• Regularly lead and conduct internal governance compliance audits of research studies across the Trust’s portfolio, applying formal audit methodology to assess compliance with GCP and Trust SOPs; analyse audit findings, identify trends and systemic risks, and develop and implement corrective action plans.
• Maintain a regular programme of compliance monitoring across all active research studies, including at least monthly review of governance KPIs, documentation quality, protocol adherence and regulatory correspondence.
• Monitor data quality and maintain quality control procedures across all active studies.
• Process, document and communicate protocol amendments in accordance with GCP and Trust SOPs; ensure sponsor and ethics approvals are obtained prior to implementation.
• To ensure all study documents are archived according to sponsor and Trust requirements and SOPs/policies, and a formal retrieval system is in place within the research team.
• Initiate and lead robust risk management activities for research study activity, identifying areas of non-compliance, escalating serious breaches to the Research Governance Manager and implementing remedial measures.
• Liaise with clinical investigators and research teams regarding the appropriateness of financial templates and activity costings; negotiate with sponsors where further discussion is required.

For Trials Sponsored by MCHFT

• Liaise with the Core Research Team, Clinical Trials Pharmacy team, laboratories, radiology, and finance, regarding feasibility and resource requirements of proposed studies.
• Liaise with NIHR RRDN for studies adopted to the portfolio.
• Ensure Trial Steering Committees (TSCs) and Data Safety Monitoring Boards (DSMBs) are appropriately constituted, that terms of reference are in place, and that meetings are organised as required.
• Contribute to the development of key trial documents including Schedules of Investigations, Patient Information Sheets, Informed Consent Forms, GP letters, data collection tools, Case Report Forms and Adverse Event reporting forms.
• Assess and monitor study team capacity relative to current workload to ensure the safe and compliant conduct of proposed and active studies.

Policy and Service Development

• Lead the development and implementation of research governance SOPs and policies within the R&D department, ensuring they reflect current national guidance, HRA requirements and Trust standards, and that all research staff are trained accordingly.
• Proactively identify opportunities to improve governance workflows and service delivery within R&D; propose and implement changes to working practices and procedures that may have impact across the wider research team and Trust research operations.
• Contribute to Trust-wide research governance policy development by working collaboratively with the Research Governance Manager, Director of R&D, and other relevant teams to ensure policies are current, evidence-based and operationally effective.
• Monitor changes to national research governance legislation and regulation; assess their impact on Trust research activity and recommend and implement appropriate changes to local policies and procedures.

Financial and Resource Management

• Ensure financial arrangements are in place for all studies, including cost recovery, invoicing schedules and management of travel and participant expenses.
• Track, monitor and reconcile payments throughout the lifecycle of each study, ensuring all payments are made and received in line with agreed schedules.
• Liaise with Trust Finance and the R&D Core Team regarding income generation, invoicing, and financial reporting.

Managerial / Leadership

• Ensure a healthy, safe and secure working environment, ensuring compliance with legal and regulatory requirements, maintaining accurate documentation and reporting any concerns.
• To provide line management to Administration Assistants within the R&D team, including day-to-day supervision, work allocation, annual performance review, identification of development needs, and maintenance of Personal Development Plans.
• Support the Research Governance Manager with recruitment, retention, and management of R&D administrative staff.
• Actively manage sickness/absence, applying Trust policies and supporting staff welfare within agreed targets.
• Coordinate the education and training needs of administrative staff, ensuring mandatory training compliance, induction, GCP training, system-specific training (IRAS, EDGE) and other identified development needs are met and recorded.
• Ensure Trust mandatory training is undertaken and recorded within R&D within specified timeframes for all staff within line management responsibility.

Education /Learning

• Take responsibility for own learning and development by recognising and taking advantage of all opportunities to learn, including full participation in KSF/appraisal, supervision, action learning and by maintaining a professional/personal portfolio of learning.  All learning and development responsibilities including supporting the training of others standard statement as below to be included
• Keep abreast of Trust-wide research SOPs and national policies and ensure the research team is aware of changes and conducting research in line with current requirements.
• Participate fully in annual appraisal and KSF review, maintaining a professional portfolio of learning and development.