Medical Ethics jobs in Manchester

We are seeking a Sponsorship Governance Facilitator to join the Sponsorship Team within the R&I Office at the Christie NHS Foundation Trust.

This is fantastic opportunity for an individual with clinical research management experience looking to take on a research governance role.

The post holder will provide advice and regulatory support to researchers from confirmation of grant application, through sponsorship and regulatory approval, initiation at sites, study conduct and close-down; ensuring studies meet regulatory requirements and other obligations as Sponsor, and working closely with investigators, project managers, internal research support services and external collaborating organisations throughout the lifecycle of a research study.

The study portfolio will include CTIMPs, device trials, surgical and interventional trials, basic science studies involving procedures with human participants, observational studies, qualitative research and studies working with tissue or data. The post holder will be required to work autonomously, managing their day-to-day workload and prioritising as needed.

As a key member of the sponsor team, you will provide regulatory support and advice to researchers and collaborators throughout the lifecycle of a portfolio of research studies, supporting the Trust to meet its obligations as research sponsor.

Ensuring a risk-based and collaborative approach you will provide ongoing oversight of study progress and key performance indicators to ensure that studies within the portfolio meet key milestones and all regulatory reporting requirements.

You will be required to liaise with external collaborators funding agencies (including industry, charities, Department of Health & Social Care, NIHR), and other organisations and Trust departments as required.

The ideal candidate will be proactive, highly organised and proficient in communicating with a wide range of stakeholders, as well as having the ability to navigate complex and competing priorities.

This post holder will have a strong understanding of standards and legislation that govern research practice in the NHS.

The Christie is one of Europe’s leading cancer centres, looking after more than 64,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 25% patients are referred to us from other parts of the country.

We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.

We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK’s National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.

Governance and Management

To be a sponsorship specialist for an allocated portfolio of Trust research studies and as such have significant discretion and freedom to act.

Provide guidance to investigators on the requirements for Christie sponsorship.

Advise and support investigators and Research Managers in ensuring appropriate costings are included in studies; to provide resource for sponsorship responsibilities at the grant application stage of agreeing provisional sponsorship or when initially presented with an internally funded study.

Support investigators with compiling documentation for regulatory submissions; Health Research Authority (HRA) including HRA assessment, Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC), Confidentiality Advisory Group (CAG) and site requirements by advising and reviewing documentation.

Review all study related documentation to ensure it is of high standard, consistent with current regulatory requirements and advisory guidance and meets Trust sponsor obligations such as adequate peer review, risk assessment and data management. Ensuring data management plans are in place and that assurances are obtained to verify that the databases are fit for purpose.

Ensure the provision of Investigational Medicinal Product (IMP), placebo or devices as appropriate from approved providers to cover the duration of the trial.

Collaborate with the contracts team to assess and advise on contracts required and provide template documents for the necessary contractual requirements of the study. Review responsibilities, liaise with third parties as required and obtain appropriate authorisations for contracts, sponsorship agreements and study vendors.

Conduct sponsor review of study amendments, ensuring implications are assessed communication and functional areas involved as necessary prior to and changes being actioned.

Implement and follow sponsorship related SOPs.

Contribute to the development maintenance of sponsorship related SOPs and ensure their compliance with regulatory and Trust requirements. Implement changes to policy, and relevant SOPs, when national guidance changes within the sponsorship arena.

To contribute and assist in the preparation for external audit, monitoring and regulatory inspection by external agencies such as the MHRA.

Co-ordinating remedial action and ensuring completion of tasks in relation to CAPA planned following monitoring, audit. Inspection or incident/deviation related issues.
Portfolio Oversight

Work within sponsorship team to ensure routine processes implemented to meet sponsor obligations during study set-up, green-light (including other sites), regulatory reporting (e.g. progress reports and end of study reports), study closure and study results and publications.

Work to ensure activities are well planned and organised and tracked due to the varied nature of specific studies and the unpredictable workload involved.

Provide oversight of the management of Trust sponsored studies. Ensuring Trial Management Group meetings take place and attend where required, ensuring Trial Steering Committees and Data Management Committees are in place as required. Ensuring Clinical Trials Units, or other vendors, undertake their delegated contractual duties appropriately and in a timely fashion. Ensure Study Initiation Visits (SIVs) have taken place when required.

Receive and review progress reports as determined by the study risk management plan – escalating any concerns as necessary.

Manage to resolution issues identified through the Trust monitoring and audit programme, which are the sponsor’s responsibility to action and oversee.
Information Management

Maintain precise and accurate records that document the decisions made on behalf of the sponsor for the lifetime of the study.

Responsible for the operation of sponsor information systems (project planning tools and trackers) – managing and maintaining the data within and developing where required for the Trust.
Finance

Contribute to the oversight of study budgets by working with the R&I grants and income and costing functions.

Work with project teams and cross functional teams to ensure that study budgets are reconciled in a timely manner at the end of the study.
Communication

Engage actively with investigators, academic collaborators, clinical research fellows, nurses, support departments, academic departments and external organisations to ensure they receive appropriate and tailored support.

Ensure all stakeholders are informed and involved at every level of sponsorship reviews.

Provide investigators with the necessary information on NIHR, HRA, MHRA and Trust processes. This may include multidisciplinary meetings, website and producing and maintaining other information materials.

Answer queries relating to legislation and the conduct of research from research staff promptly and efficiently. This information may be complex in nature, so good communication skills are required to make the information understandable to varying levels of staff. Acknowledging all communication from investigators and key stakeholders and ensuring an efficient flow of information.

Ensure there is good internal communication, with members of R&I infrastructure staff, of decision making and sponsorship pathway progress. Tact and sensitivity will need to be used when delivering negative news to recipients.

When communicating with external organisations, such as CTUs or other vendors, professionalism, persuasion, negotiation and assertiveness will be required to ensure the Trust receives the services required. There may also be a need to discuss shortcomings of the service being delivered where necessary in conjunction with other members of the R&I team.
Human Resources Management

Provide effective leadership on sponsorship matters and know when to escalate to sponsorship manager.

Participate in recruitment of staff to the R&I central office and act as supervisor/mentor as required.