Job summary

This new role involves working within the research delivery and the project support team of the Cardiovascular Research Department. The team is responsible for the set-up and delivery of research studies within Cardiology, Vascular and Cardiac Surgery speciality.

The post holder will project manage multiple studies and work closely with the clinical delivery team, project support team and other staff to ensure studies are set up quickly, completed on time, to target, within budget, and in-line with regulatory requirements and good clinical practice.

This is a wide ranging role with many tasks between feasibility, study set-up to data-lock coming under the responsibility of the project manager. There will also be involvement in study finances.

Main duties of the job

The post holder will be expected to work closely with the senior research nurses and the Cardiovascular Research Manager to report progress of studies and recruitment statuses to senior staff including Principal Investigators and the Cardiovascular Research Operations Director; trouble shoot, and develop and instigate recovery plans if studies are not running according to plan.

You will delegate trial specific tasks to the project team e.g. research governance administrator(s) and/or Administrators and/or delivery personnel to facilitate study delivery. You will train and develop these members of staff to ensure they are able to carry out their study specific tasks, and to monitor their progress and effect remedial solutions when, and if, required.

About us

Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030).

We have four primary goals:

• high-quality care for all,
• being a great place to work,
• partnerships for impact, and
• research and education excellence

And we will embed health equality in all we do - taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities.

Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all:

• we are compassionate,
• we are proud,
• we are inclusive, and
• we are one team

This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve.

About the University Hospitals of Leicester NHS Trust:

https://www.uhleicester.nhs.uk

Job description

Job 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

• The main working relationships that the post holder will be required to develop include;
• 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

Key result areas for this post include;

• 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 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 form 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 patients and staffs records.

All employees must comply with the Trusts 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.

In order to ensure the Trusts ability to respond to changes in the needs of the service, after appropriate consultation anddiscussion with you(including consideration of personal circumstances current skills, abilities and career development) the Trust may make a change to your location, duties and responsibilities that are deemed reasonable in the circumstances.

Your normal place of work will be as discussed at interview and will be confirmed in Section 1 of your contract but you may be required to work in other locations of the Trust. In particular, flexibility is required across the three main Hospital sites (Leicester Royal Infirmary, Leicester General Hospital, Glenfield Hospital). If your initial location is based at one of these sites, excess travel reimbursement will not apply for a permanent/temporary change to base.

Job description
Job 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

• The main working relationships that the post holder will be required to develop include;
• 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

Key result areas for this post include;

• 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 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 form 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 patients and staffs records.

All employees must comply with the Trusts 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.

In order to ensure the Trusts ability to respond to changes in the needs of the service, after appropriate consultation anddiscussion with you(including consideration of personal circumstances current skills, abilities and career development) the Trust may make a change to your location, duties and responsibilities that are deemed reasonable in the circumstances.

Your normal place of work will be as discussed at interview and will be confirmed in Section 1 of your contract but you may be required to work in other locations of the Trust. In particular, flexibility is required across the three main Hospital sites (Leicester Royal Infirmary, Leicester General Hospital, Glenfield Hospital). If your initial location is based at one of these sites, excess travel reimbursement will not apply for a permanent/temporary change to base.

Person Specification

Training and Qualification

Essential

• 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

• Project Management Qualification
• *Higher degree qualification (e.g. MSc) in clinical trials or a health related discipline.

Experience

Essential

• 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

• Experience of electronic data capture (eCRF) systems
• Experience of commercial clinical trials
• Previous NHS experience
• Data quality management

Planning and Organisation

Essential

• Project Management Skills
• Planning and organisational skills, with a methodical approach and the ability to pay attention to detail.

Desirable

• Understand and use project management tools

Communication and relationship skills

Essential

• 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

• 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

• Leadership and motivational qualities.
• Ability to work to deadlines/stability under pressure
• Ability to exercise initiative
• Ability 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

• 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

• Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours

Physical skills

Essential

• Ability to travel to other sites within UHL and the wider area

Equality and Diversity

Essential

• Able to demonstrate a commitment and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.

Person Specification
Training and Qualification

Essential

• 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

• Project Management Qualification
• *Higher degree qualification (e.g. MSc) in clinical trials or a health related discipline.

Experience

Essential

• 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

• Experience of electronic data capture (eCRF) systems
• Experience of commercial clinical trials
• Previous NHS experience
• Data quality management

Planning and Organisation

Essential

• Project Management Skills
• Planning and organisational skills, with a methodical approach and the ability to pay attention to detail.

Desirable

• Understand and use project management tools

Communication and relationship skills

Essential

• 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

• 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

• Leadership and motivational qualities.
• Ability to work to deadlines/stability under pressure
• Ability to exercise initiative
• Ability 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

• 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

• Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours

Physical skills

Essential

• Ability to travel to other sites within UHL and the wider area

Equality and Diversity

Essential

• 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

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.
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Additional information
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.
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Employer details

Employer name

University Hospitals of Leicester NHS Trust
Address

Cardiovascular Research, Glenfield Hospital

Groby Road

Leicester

LE3 9QP

United Kingdom

Employer's website