Research Regulatory Compliance Manager

Job description

Job responsibilities

Detailed Job Description Patient/customer care (both direct and indirect)

To be the lead contact within the Trust providing advice, training and support to investigators on compliance with the UK Policy Framework for Health and Social Care, Medicines for Human Use Act and all applicable legislation relating to MHRA regulated studies. This will include:

• To meet and provide advice to research staff across the Trust as required to discuss any GCP or regulatory compliance issues
• To develop and deliver a programme of training for all researchers working in the Trust in relation to regulatory compliance
• To ensure that all staff, particularly those involved in Trust-sponsored regulated studies, are aware of their responsibilities and that studies are conducted appropriately in accordance with all relevant legislation, explaining the requirements of the law and ensuring that responsibilities are delegated appropriately and that all team members understand their responsibilities
• To undertake a robust monitoring and audit framework for regulated clinical trials in order to mitigate the risk of any breach in regulations resulting in patient harm as a result of being involved in research activities at the Trust

To be responsible for the development and amendment of Trustwide standard operating procedures relating to clinical trials in order to ensure the Trust is fully compliant with the complex requirements of the UK Policy Framework for Health and Social Care, Good Clinical Practice, EU directives and UK-specific regulations (Statutory Instruments) for CTIMPs, ATMP and Medical devices

To develop and be responsible for the development and amendment of any other Trust policies to ensure compliance with other research regulations

To contribute towards the ongoing oversight of Trust standard operating procedures relating to research governance and ensure that these are kept up to date and amended appropriately in the light of new requirements or developments in the UK Policy Framework for Health and Social Care

To work closely with the Trust R&D Department, researchers and other stakeholders as appropriate to implement changes to processes in order to ensure regulatory compliance with Trust policies for research

To be responsible for the Trusts oversight and monitoring processes for regulated clinical trials to ensure that the Trust is compliant with research regulations and Trust policies associated with the UK Policy Framework for Health and Social Care for CTIMPs (clinical trial of an investigational medicinal product) and other regulated studies

Compliance with EU Directives, UK Legislation and regulations for clinical research

To work closely with the Director, Assistant Director, Research Delivery Operations Manager to ensure that the Trust complies with and oversees all regulatory requirements in the context of the Medicines for Human Use Act and any other applicable legislation

To be familiar with all clinical research protocols for CTIMPs at the Trust and ensure that processes are in place to ensure GCP compliance. A specific focus will be Trust-sponsored regulated studies

To coordinate and lead activities relating to preparation of any future statutory MHRA Inspections in conjunction with the Assistant Director of R&D, the R&D Office, service departments and local investigators. Ensure that all relevant staff groups are adequately prepared for any pending inspection

To be responsible for writing new, and updating existing, standard operating procedures and guidance to ensure the implementation of statutory and regulatory requirements for clinical research studies in the Trust

To ensure that the Trust implements any changes to SOPs or guidelines related to developments in national and local research governance policy

Set-up of Trust-sponsored regulated studies

To assist Trust researchers with regulatory submissions to the MHRA

To be responsible for the governance review of all Trust-sponsored MHRA regulated studies, working closely with the Research Delivery Operations Manager

To oversee trial initiation meetings with Chief/Principal Investigators and other staff (e.g. the Clinical Trials Pharmacist) to ensure CTIMPs are conducted appropriately and in accordance with all relevant legislation, to ensure responsibilities are delegated appropriately and to ensure that teams understand their responsibilities

To support research teams in setting up Trial Master Files/ Investigator Site Files for regulated clinical trials sponsored by the Trust

To manage the risk assessment process for all regulated clinical trials in the Trust

To establish and agree appropriate monitoring and audit plans for all regulated clinical trials in the Trust. Monitoring will include:

1. Review of trial master file documentation
2. Review of consent forms
3. Source data verification
4. Review of adverse event reporting
5. Ensuring compliance with protocol and SOPs
6. Review of support departments e.g. pharmacy, laboratory medicine etc

To maintain documented evidence of monitoring, audit and inspection. To analyse trend and issues in order to proactively identify and implement preventative measures in order to improve the service

To review the outcome of monitoring visits and audits and to work with the R&D Team in ensuring follow up and implementation of actions and recommendations listed in the monitoring report

To manage the pharmacovigilance systems within the Trust in the form of SOPs, audit tools and information packs for researchers that meet regulatory requirements of the MHRA

To support and advise researchers with reporting adverse events appropriately to the MHRA and REC and assisting with other pharmacovigilance queries

To ensure the timely submission of Annual Safety Reports, Development Safety Update Reports (DSURs), end of study reports and Clinical Trial reports.

To be the point of contact on archiving within the Trust for regulated Trust-sponsored clinical trials and ensure that study closure and archiving procedures are compliant with research regulations and are followed by researchers in the Trust

To participate in the delivery of research governance training programmes in the Trust (e.g. research training, research induction and GCP courses), working with other researchers, the R&D Office and the Trusts Research Strategy Board, where required, in order to deliver these programmes

To constantly review, and update where necessary, the impact (compliance, feedback and effectiveness) of research training programmes within the Trust for regulated clinical trials

To provide training on adverse event reporting and safety reporting to relevant staff groups

To line manage the following posts in the Trust R&D Department:

• • Trial Managers/Officers working on Trust sponsored regulated studies
  • To be responsible for the recruitment, selection and management of the above staff.
  • To ensure that the above staff have individual development review and a personal development plan.
  • To ensure that the above staff receive the necessary training, support and supervision
  • To provide proactive support, advice and assistance to R&D Office staff on regulatory issues related to clinical research in the UK

To meet and advise clinical trials coordinators/research nurses, as required, on GCP/regulatory compliance issues

To be responsible for ensuring that all new research staff in the Trust receive appropriate training prior to commencement of their research activities. Organising and delivering training which will include a substantial contribution from the post holder around the areas of his/her responsibility

To inform the Assistant Director of Research and other managers in the Trust R&D Department of any changes in regulations and any subsequent actions required across the Trust

To be the Trust lead for advice on clinical trial regulations

To liaise effectively with clinical trials units, internal and external investigators and support staff in order to ensure that the Trusts policies and processes are followed in order to ensure regulatory compliance

To develop effective communication and collaborative working with counterparts at Imperial College London in order to ensure compliance within the Trust on regulatory issues

To ensure that the R&D intranet contains up to date and relevant information relating to regulatory compliance SOPs. Ensure that all researchers are advised and issued with updated relevant SOPs

Write and present written discussion papers, policy documents etc. for a variety of audiences within the Trust and for publication on the Internet

To represent the Trust externally as requested, but primarily at committees/meetings focussed on running regulated clinical trials, research governance policy and the Medicines for Human Use Act

To ensure the Trust has auditable systems that satisfy MHRA GCP Statutory Inspections

To ensure the R&D Office maintains a control register log of all regulated research studies on-going and completed within the Trust

To manage the budgets of Trust sponsored regulated studies working closely with the Assistant Director of Research and Research Lead Finance Manger

Person Specification

Education and Qualification

Essential

• Post graduate qualification /equivalent related to research, training in GCP and Monitoring

Experience

Essential

• 5 years in NHS and clin research, UK Policy Framework, CTIMP sponsorship
• Management/writing or SOPs and policies experience, Knowledge of HTA

Desirable

• MHRA audit and Monitoring in CTU - experience

Skills and Knowledge

Essential

• Communication and organisation skills (general format of application

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.

Employer details

Employer name

Chelsea and Westminster Hospital NHS Foundation Trust

Address

Chelsea and Westminster Hospital - Research Department

Harbour Yard, Chelsea Harbour

London

SW10 0XD

Employer's website

https://www.chelwest.nhs.uk/ (Opens in a new tab)