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UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria.
Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible.
UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs.
Detailed job description and main responsibilities
* You will work across all UHL sites as required, will liaise with sponsors, contract research organisations, the Clinical Research Network, and other external organisations such as other Trusts.
* There may be a very occasional need to undertake flexible working arrangements to meet project demands i.e. working some early and late shifts and occasional weekends. There may be the need to attend meetings nationally.
* Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting.
SCOPE
Budget
* You will work with the Research Delivery Team to ensure expenditure is recorded accurately to enable accurate invoicing of sponsors. To ensure expenditure remains within limits and that there is value for money on all expenditure. Follow in-house finance scheduling processes and reporting, and liaise with R&I finance lead to action raising of invoices in a timely manner.
Staff
* To line manage junior staff, ensuring that all aspects of performance, attendance, sickness absence, training and appraisal are addressed in accordance with Trust Policy.
Policy
* Adhere to all Trust and sponsor policies, research governance framework, information governance and data protection act, Good Clinical Practice and the standard operating procedures assigned to each study the post holder works on.
Communications
* Post holder will be a strong and transparent communicator.
KEY WORKING RELATIONSHIPS
* CV Research Manager
* CV Research Operations Director
* Senior Research Nurses
* Chief/Principal Investigators
* Department clinical team
* Study sponsors/contract research organisations
* R&I department
* Clinical trials pharmacists
* Clinical Research Network East Midlands
KEY RESULT AREAS
* Timely set-up of studies.
* Delivery of studies to time and target.
* Timely and accurate reporting of the progress of studies and finances.
* Efficient and effective staff training for study related procedures/processes.
* Efficient and effective set-up and maintenance of internal study management system.
* Develop and maintain good working relationships across the department.
* Develop and support staff that the post holder line manages.
* Oversight of efficient and effective set-up and maintenance of site files.
* Keep all training up to date (mandatory and study related) and seek personal development opportunities.
* Ensure that study data is accurate and robust.
* Ensure that the project(s) is delivered within allocated budget and ensure departmental invoicing processes are followed within the expected timelines
* Ensure the effective use of trust resources
* Support grant development with obtaining NHS costings from R&I Finance, when required.
* Management of study recruitment which will include the development of recruitment plans and the leadership of recruitment strategies for example community events, leaflet drops etc.
* Adhere to ICH-GCP
GENERAL DUTIES
In addition to the key job responsibilities detailed in this job description all employees at UHL NHS Trust are expected to comply with the general duties detailed below:
Undertake any other duties that may be required from time to time that are consistent with the scope and sphere of influence of the project aims and objectives.
All employees are subject to the requirements of the Health & Safety at Work Act. The post holder is required to ensure that as an employee, his or her work methods do not endanger other people or themselves.
All employees are subject to the requirements of the Data Protection Act and must maintain strict confidentiality in respect of patient's and staff's records.
All employees must comply with the Trust's equality and diversity policies and must not discriminate against individuals or groups on the basis of their age, disability, gender, marital status, membership or non-membership of a trade union, race religion, domestic circumstances, sexual orientation, ethnic or national origin, social and employment status, HIV status, or people who are undergoing or have undergone gender re-assignment, marriage and civil partnership, pregnancy and maternity or any other grounds which cannot be shown to be justifiable.
This job description is not to be taken as an exhaustive list of duties and it may be reviewed in the light of changed service needs and development. Any changes will be fully discussed with the post holder. The post holder will be required to carry out the duties appropriate to the grade and scope of the post.
Person specification
Training and Qualification
Essential criteria
* Degree / or equivalent qualification in a science or health related discipline or a degree in another field with experience in clinical trials.
* Experience within a supervisory/management role.
* Good Clinical Practice certificate
Desirable criteria
* Project Management Qualification
* Higher degree qualification (e.g. MSc) in clinical trials or a health related discipline.
Experience
Essential criteria
* Experience of running and/or managing clinical research studies/trials.
* Experience of working in a large complex multi professional organisation.
* Knowledge of national and local research approval processes i.e. HRA and MHRA processes, and site capacity and capability requirements.
* Sound knowledge of the principles of research governance
Desirable criteria
* Experience of electronic data capture (eCRF) systems
* Experience of commercial clinical trials
* Previous NHS experience
* Data quality management
Planning and Organisation
Essential criteria
* Project Management Skills
* Planning and organisational skills, with a methodical approach and the ability to pay attention to detail.
Desirable criteria
* Understand and use project management tools
Communication and relationship skills
Essential criteria
* Ability to work autonomously
* Ability to work effectively within a team
* Facilitation skills
* Excellent communication skills written and verbal - able to communicate at all levels with well-developed networking and influencing skills.
Analytical and Judgement skills
Essential criteria
* High level of computer literacy
* Competent with Microsoft software (Word, Excel and Powerpoint)
* Understand, interpret and critically analyse data and information and prepare progress reports.
Skills
Essential criteria
* Leadership and motivational qualities.
* Ability to work to deadlines/stability under pressure
* Ability to exercise initiativeAbility to prioritise own and others workload and practice effective time management.
* Excellent presentation skills.
* Understand and use quality management systems
* Actively manage own personal development.
Other requirements specific to the role
Essential criteria
* Ability to work flexibly
* Ability to work as part of a team
* Ability to establish and maintain credibility
Commitment to Trust Values and Behaviours
Essential criteria
* Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours
Physical skills
Essential criteria
* Ability to travel to other sites within UHL and the wider area
Equality and Diversity
Essential criteria
* Able to demonstrate a commitment and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
Disclosure and Barring Service Check
Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check.
The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment.
COVID 19 Risk Assessment
Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer.
The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors.
If it is identified that you are within a vulnerable category, we will endeavour to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager.
Covid Vaccination Status
Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated.
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