Senior Study Support Service Facilitator

Job responsibilities

MAIN TASKS AND RESPONSIBILITIES:

1. Service Delivery & Development
   • Project manage the setup of a portfolio of multiple research projects, ensuring that studies are set up in a timely manner and in line with the NIHR Clinical Research Network High Level Objectives.
   • Monitor the delivery of research projects ensuring that studies recruit to time and target, identify barriers to recruitment and take appropriate actions to remove them.
   • Develop effective working relationships with clinicians, sponsors, research managers, delivery staff, clinical and non-clinical support departments
   • Report on project progress and facilitate the resolution of operational issues at any of the Organisations affiliated with the CRN.
   • Work on projects autonomously and escalate issues to senior management only when required by the circumstances.
   • Undertake service improvement projects in various functions of the Clinical Research Network.

1. Governance
   • Provide regulatory advice to researchers, sponsors and other colleagues within the Network.
   • Advise researchers on the contractual requirements for NHS and non-NHS staff of the Research Passport Scheme and implement as necessary.
   • Support, facilitate and in many cases lead study set-up in other areas of the country for multicentre studies led from CRN East Midlands, building important relationships to facilitate this.
   • Manage study activity identification and cost attribution in line with the Department of Healths guidance (i.e. AcoRD).
   • Negotiate with other branches of the CRN to ensure that service support is secured for multicentre studies led from CRN East Midlands.
   • Support with rapid contract sign off and costing process to facilitate efficient study set up.
   • Work in accordance with the research governance framework, HRA guidance, ICH GCP and EU/UK guidelines and facilitate regulatory compliance within the Network.

1. Patient/Customer Service
   • Develop and maintain good working relationship with all staff across the Clinical Research Network and its partner organisations.
   • Develop effective working relationships with clinicians, sponsors, research managers, delivery staff, clinical and non-clinical support departments.

1. Research
   • Support researchers at the pre-application to funding bodies stage in the cost attribution of activities and provide information and signposting on the NIHR Study Support service offerings.
   • Facilitating timely agreement of costs for commercial and non-commercial research.
   • Manage the setup of commercial and non-commercial research in any of the partner organisations of the Clinical Research Network East Midlands.
   • Investigate the feasibility of study participation, liaising with relevant parties involved, to ensure that sites can successfully recruit to time and target. Feasibility coordination will involve information gathering from study teams, investigators, research nurses, research managers, clinical and non-clinical departments and committees, as well as using databases to derive accurate recruitment targets.
   • Facilitate the expressions of interest process, identify suitable Principal Investigators, liaise with the Chief Investigators team and/or Sponsors to ensure successful site selection.
   • Advise on the preparation for REC/HRA and NHS Organisations/IHSPs processes for Assess Arrange Confirm (including completion of IRAS).
   • Liaise with stakeholders, both internal and external, to ensure timely study setup and initiation of studies.
   • Represent CRN at study meetings.
   • Assist research delivery teams in ensuring that studies recruit to time and target.
   • When required, assist the Clinical Research Network with any other duties relating to study management or office administration.

GENERAL

The post holder will be expected to keep up-to-date with local and national developments in the Clinical Research Network. S/he will need to understand the broader vision of the Clinical Research Network and how the Study Support Services function fits into the larger CRN structure.

The post holder will have supervisory / line management responsibility of Study Support staff.

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:

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 Equal Opportunities Policy and must not discriminate on grounds of age, colour, race, nationality or ethnic origin, religion, belief, gender, marital status, sexuality, disability, trades union membership (or non-membership) or political affiliation, 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 and discussion 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.

You will be required to maintain compliance with all statutory and mandatory training requirements.

Your normal place of work (either Leicester Royal Infirmary or Queen's Medical Centre, Nottingham) 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 UHL Trust and/or the Network Partner Organisations. In particular, flexibility is required across the three main UHL 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.

Training & Qualifications

Essential

• Educated to degree level or equivalent relevant experience

Desirable

• Postgraduate level degree
• Project Management Training
• GCP Training

Experience

Essential

• Firm knowledge of the Clinical Research Network and its operations
• Experience of working in a clinical research environment
• Specialist knowledge of the clinical trial process
• Experience of working with NHS organisations in the conduct of clinical research
• Knowledge of Department of Health AcoRD guidance
• Excellent track record of meeting deadlines and delivering objectives in a timely manner
• Experience of project management
• Excellent IT skills
• Experience of using databases and IS systems
• Experience of working with spreadsheets and databases

Desirable

• Knowledge of research governance and clinical trial regulations (eg ICH GCP, EU/UK regulations)
• Knowledge of NIHR industry costing template
• Clinical trial management experience (commercial/non- commercial)
• Experience of managing regulatory submissions
• Experience of costing research

Communication and relationship skills

Essential

• Ability to communicate complex information both written and orally to a range of audiences at both local and network wide level
• Ability to deliver feedback in a positive, constructive manner.
• Ability to manage challenging behaviour and difficult situations in a diplomatic and professional manner
• Excellent negotiation skills
• Ability to communicate with industry sponsors and build relationships while remaining professional and presenting a positive representation of both the East Midlands LCRN and partner organisations.
• Ability to build working relationships and gain the respect of others
• Ability to persuade and positively influence other team members and work colleagues.
• Ability to work well in a team and to to work independently as required.

Analytical and Judgement skills

Essential

• Ability to read and interpret complex documents including research protocols
• Ability to accurately interpret and present data in appropriate formats
• Ability to apply information from data bases to recruitment plans and identify issues which require escalation
• Ability to process and collate information quickly and to be able to make well informed judgements in a timely manner.
• Ability to learn new information, procedures and processes in a limited time period e.g. familiarise oneself with a complex study to be able to support researchers or Industry Team at the coordinating centre with tasks that require completing within short deadlines.
• Good problem solving skills with the ability to make well informed decisions on a continuous basis

Skills

Essential

• Adopts a flexible approach
• Can work both independently and as part of a team
• Ability to motivate themselves and others
• Self -awareness and understanding of own strengths and limitations and impact of personal style and approach on others
• Commitment to openness, honesty, inclusiveness and personal integrity in dealing with others
• Commitment to continuing professional development
• Sets and achieves high standards for own behaviour and personal presentation

Planning and organisation skills

Essential

• Excellent planning and organisational skills, with the ability to prioritise and work to multiple deadlines
• Ability to work to local and national deadlines, objectives and targets
• Ability to work to deadlines when completing study budgets and contract negotiations and other designated timelines
• Ability to identify and establish agreed workload/tasks with study site teams, Industry sponsors/contract research organisations, CRN AND LCRN team members and other NHS organisation contacts
• Ability to work independently

Other requirements specific to the role

Essential

• Awareness of Equality & Valuing Diversity Principles
• Understanding of Confidentiality & Data Protection Act
• Ability to travel between the sites in the East Midlands region and nationally as required
• Engages with and promotes continuous improvement projects
• Willing to use "hot desking" facilities
• Ability to use manual handling skills to transport documentation and equipment in a safe manner
• Ability to work for long periods on a computer, including use of a keyboard on a daily basis
• Ability to be able to manage long periods of concentration and pressured work

Equality, Diversity and Inclusion

Essential

• Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs
• All staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others

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 UK Visas and Immigration website (Opens in a new tab).

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. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).