Detailed job description and main responsibilities
DUTIES AND RESPONSIBILITIES
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.
Person specification
Qualifications
Essential criteria
* Post graduate diploma level in a scientific discipline or equivalent experience
Desirable criteria
* Evidence of continuing professional development
Experience
Essential criteria
* Previous experience of working within clinical research setting
* Experience of writing procedural/patient documentation
* Experience of working to deadlines
Skills
Essential criteria
* Ability to assess and interpret complicated and conflicting information and use judgement where appropriate.
* Ability to listen to others and use critical questioning techniques to identify core issues/risks within proposals
* Organisational and time management skills
* Interpersonal skills- Good written and oral communication skills
* Ability to work under pressure to tight timelines
Desirable criteria
* Ability to use spreadsheets
* Ability to create PowerPoint presentations and other Microsoft office applications.
* Advanced computer literacy and ability to adapt and learn new computer applications.
Knowledge
Essential criteria
* Knowledge of research sponsorship responsibilities.
* Comprehensive knowledge and understanding of standards and legislation that govern research practice in the NHS.
* Comprehensive knowledge and understanding of NHS research governance processes, including amendments.
* Knowledge of regulatory issues surrounding the conduct of clinical research
* Awareness of research within the NHS and legislative framework within the UK.
Desirable criteria
* Knowledge of quantitative and qualitative research methodologies.
* Understanding of clinical trial protocol requirements.
* Understanding of study data management systems.
* Knowledge of international research, and conduct.
Other
Essential criteria
* Able to work and act independently.
* Ability to work across functional and organisational boundaries.
* Good attention to detail.
* Positive approach.
* Flexible and motivated team player
The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.
We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.
We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.
As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy
All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.
By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.
If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.
The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.
Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.
You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.
Employer certification / accreditation badges
Documents to download
* Job Description And Person Specification (PDF, 248.4KB)
* The Christie Values and Behaviours (PDF, 919.5KB)
* Strategy Brochure (PDF, 1.0MB)
* Travel to The Christie (PDF, 3.8MB)
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