Clinical Trial Delivery Team Lead

Job description

Job responsibilities

PRIMARY DUTIES & AREAS OF RESPONSIBILITY:

1. To ensure effective working relationships with Research & Development (R&D) Senior Leadership Team, (R&D Clinical Director, R&D Operations Director and Lead Research Nurse), Research Nurse/Practitioner Specialist team, wider Clinical Trial Delivery team, R&D Clinical Educator, R&D Data and Admin teams, as well as R&D function teams such as finance, operations and governance in order to lead the Clinical Trial Delivery team (circ 84 staff) reporting to the Lead Research Nurse.

2. To ensure good relationships and communication are maintained with stakeholders such as the NIHR (National Institute for Health and Social Care Research), HEIs (Higher Education Institutions), partners across the integrated care pathway, Senior managers and colleagues across the trust.

1. The post holder will be responsible for recruiting to and line managing the research specialist nurse/practitioner Band 7 team (circa 9 staff) who lead clinical trial delivery teams to ensure the trials that UHP is supporting are conducted to the highest standards.
2. This post will be supporting the R&D Senior Leadership team ensuring that exacting standards are met with our clinical delivery team, training, and systems.

COMMUNICATION AND WORKING RELATIONSHIPS:

5. Establish and maintain good working relationships within the Clincal Trial Delivery team to ensure they are working to the current R&D strategy.

1. Support the R&D Senior Leadership Team with strategic and annual plans for supporting research growth across our region, consulting to maximise research capacity and capability.

7. Able to report complex data sets to the R&D Senior Leadership Team on clinical trial delivery team performance, that is driven through the Edge software system and R&D dashboard.

1. Promote a blame free culture in reporting incidents and liaise where appropriate with the R&D Governance manager, R&D QA Manager, R&D Clinical Educator, and wider Governance teams in UHP.

KNOWLEDGE & EXPERIENCE:

9. Maintain awareness of current advances in research and/or nursing/AHP practice using this knowledge to maintain the highest standards of research and clinical care for the staff working in R&D.

10. Develop policy, SOPs (Standard Operating procedures), miantain good workforce planning as required for the Clinical Trial Delivery team in line with these advances.

1. To have a thorough knowledge and understanding of safeguarding procedures and is knowledgeable with respect to safeguarding triggers and risks so they can advise as needed to the wider clinical trial delivery team.

12. Function as an expert resource for the clinical trial delivery team and role model for all aspects of Research Clinical Practice.

1. Able to recognise the limits of their expertise and ensure that issues they feel are out of scope of their role are appropriately escalated to the Lead Research Nurse and/or R&D Senior Leadership team in a timely manner.
2. Demonstrate professional development and an in-depth knowledge of clinical trial delivery, supplying specialist advice where needed to patients and their carers/families about their participation in clinical trials.

ANALYTICAL/JUDGEMENTAL SKILLS:

15. Monitor and plan in advance the the clinical trial delivery team workload across the team and manage team performance, ensuring good management of the clinical trial portfolio (circa 500+ studies) using digital tools to ensure good planning and implementation of clinical trial delivery of UHP portfolio of studies.

1. Lead on projects relating to the involvement of the clinical trial delivery team as well as wider projects that may support the wider R&D department.

1. Can implement and develop innovative models of care and effective patient /volunteer pathways within the clinical trial delivery team ensuring research participants receive the best service.

PLANNING & ORGANISATIONAL SKILLS:

1. In conjunction with the R&D Senior Leadership Team participate in business planning cycle, identifying areas of service development focusing on the aspects that concern the Clinical Trial Delivery team and their delivery to the portfolio of studies on behalf of the trust.

19. Able to reccommed changes or improvements to improve clinical trial delivery team performance to delivering the UHP portfolio of clinical trials in line with GCP (Good Clinical Practice) and trust policy.

SERVICE & POLICY DEVELOPMENT:

20. Ensure that education is a strong theme for the clinical trial delivery team as a whole. Advise on gaps in training and learning opportunities and working with the R&D Clinical Educator, QA Manager and Lead Research Nurse to develop strategies to overcome these.

1. Liaise with other members of the multidisciplinary team to ensure that patients and volunteers that are treated within a clinical research trial receive seamless care throughout the development of protocols and pathways.

PHYSICAL/EMOTIONAL/MENTAL EFFORT:

1. Manage any patient and/or carer/family complaints or concerns and where possible resolve these concerns, ensuring transparent feedback and support to individuals as needed, ensuring that any responses are aligning to trust policy.

23. Able to concentrate frequently for complex and intricate work and for long periods when subject to unpredictable working patterns (e.g., frequent interruptions for urgent safety investigations).

24. Able to deal with complex and unpredictable situations and successfully manage divergence of opinion within groups and/or on an individual basis.

FINANCIAL RESPONSIBILITY:

1. Work with procurement as needed to ensure equipment and supplies used by the clinical trial delivery team is available and reviewed regularly for compliance to audit standards and replaced as needed.
2. Oversee the ordering of clinical research supplies as needed for the outpatient clinic the James Lind Research Clinic and the Mobile Research Units.
3. Able to work within departmental budgetary constraints with financial responsibility.

RESEARCH & DEVELOPMENT:

1. Support colleagues across the trust as needed with their own academic research and signpost to relevant areas that can support them.
2. Support with wider objectives of the trust by contributing to Preceptorship training, induction of staff into the trust and R&D department and Chief Nurse Fellowship programmes.
3. Provide mentorship to those wishing to carry out their own research in the trust ensuring that they are signposting to others who can also support their work as appropriate.
4. Work across the clinical trial delivery teams role modelling the continuous improvement ethos by supporting change and encouraging staff to work towards excellence in their roles.

Person Specification

Qualifications

Essential

• Current registered nurse or allied health professional registered with the NMC or HCPC.
• Relevant Healthcare Degree.
• Research Training (GCP, degree module, informed consent).
• Management or Leadership Qualification.

Desirable

• Master's level qualification in a field relevant to healthcare and/or clinical research.

Knowledge

Essential

• A good working knowledge of the Research Governance Framework and the International Conference on Harmonisation Good Clinical Practice Guidelines.
• Extensive experience of clinical research in an NHS or Primary Care setting.
• Broad and recent clinical experience relevant to the post.
• Line management and leadership within the NHS.
• Experience of delivering commercial/non-commercial and academic research.
• In-depth knowledge of clinical trial delivery and research methodologies.
• Knowledge of the NIHR high level objectives and portfolio performance management.

Desirable

• Previous experience working in a leadership role at this level in a research setting.

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).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

University Hospitals Plymouth NHS Trust

Address

Research Offices, Level 2, MSCP, Bircham Park

1 Roscoff Road

Derriford, Plymouth

PL6 5FP

Employer's website

https://www.plymouthhospitals.nhs.uk/ (Opens in a new tab)