Clinical Studies Manager – Clinical Research Facility (CRF)
Job summary
The NIHR UCLH Clinical Research Facility is a well-established Clinical Research Facility covering two sites; a comprehensive Cancer and Medical research facility at 170 Tottenham Court Road, and the Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS).
We are looking to recruit an enthusiastic and self-motivated Clinical Studies Manager to join the NIHR UCLH Clinical Research Facility. This role will be based across sites at Tottenham Court Road and Queen Square, collaborating closely with the CRF Director and General Manager to develop and maintain the portfolio of studies, overseeing the systems, procedures and teams associated with the review of research studies, ensuring that commercial and non-commercial clinical trials are set up at site, opened in a timely manner and that each study is supported to reach its recruitment and performance targets.
Main duties of the job
The postholder will develop good working relationships with Principal Investigators and study sponsors, being the point of contact for sponsors. The Clinical Studies Manager will liaise with Research and Development, Principal Investigators, the pharmaceutical industry and other organisations to facilitate the efficient and effective running of trials within the portfolio. This post is a key link between the CRF and the Joint Research Office (JRO) and integral to the joint process of setting up new studies and obtaining permissions.
The postholder will be responsible for line management of CRF Trials Coordinators and will lead on the process for study feasibility, aspects of gaining Trust Confirmation of Capability and Capacity (working closely with the Joint Research Office and UCLH Service Support Departments) and trial coordination/management in the live phase of trials.
If you are a proactive and experienced individual with a passion for clinical research management, we encourage you to apply and be a part of our dynamic team.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
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University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
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National Hospital for Neurology and Neurosurgery
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Royal National ENT and Eastman Dental Hospitals
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University College Hospital Grafton Way Building
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Royal London Hospital for Integrated Medicine
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University College Hospital Macmillan Cancer Centre
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The Hospital for Tropical Diseases
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University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
Person Specification
Knowledge & Qualifications
- Educated to degree level or equivalent
- Specialist knowledge and detailed understanding of national R&D priorities and developments
- Expert knowledge of the Research Governance Framework, Health Research Authority, Human Tissue Act, Data Protection and other regulatory and legal requirements relating to research
- Knowledge of national research approval systems and priorities
- Recognised Good Clinical Practice training
- Expert knowledge of the functions and application of research governance and approval systems
- Knowledge of the legal and financial requirements relating to research approvals and delivery
Experience
- Relevant and proven experience in conducting research sponsorship and host (NHS) approvals
- Relevant and proven experience in managing complex research approvals for sponsorship and host (NHS) approval
- Evidence of maintaining complex data bases
- Experience in managing teams or individuals
- Evidence of developing Quality Assurance or Quality Check systems and procedures Evidence of report writing and submission to external parties/regulators
- Dissemination of complex, specialist information to internal and external stakeholders
- Formal PresentationsAllocation of tasks and projects to others and supervision of outcomes
- Experience in compiling and writing Standard Operating Procedures (SOPs)
- Experience of research inspections and audits (external and regulatory authorities)
Skills & Abilities
- Evidence of complex relationship building with senior stakeholders
- Advanced numeracy and problem solving skills
- Experience of working with Microsoft, Word, Excel and PowerPoint.
- Experience of using databases and of data analytical skills including the analysis of multiple sources of information to ensure compliance with targets and regulatory requirements
- Project management including independently initiating and delivery projects to targets
- Ability to prioritise conflicting and changing demands
- Ability to work independently and on own initiative
- Experience of delivering training to healthcare or research professionals
Personal Qualities
- Excellent communication skills, written and verbal
- Strong desire to share best practice and find improvements in service delivery
- Proven ability to develop effective working relationships with staff at all levels
Other requirements
- Familiarity with medical terminology
- Proven ability to proactively drive forward change and develop new systems and processes for working
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.
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.
Employer details
Employer name
University College London Hospitals NHS Foundation Trust
Address
NIHR UCLH Clinical Research Facility
4th Floor, 170 Tottenham Court Road
London
W1T 7HA
https://www.uclh.nhs.uk
- Company
- University College London Hospitals NHS Foundation Trust
- Location
- London, United Kingdom W1T 7HA
- Employment Type
- Permanent
- Salary
- £58698.00 - £65095.00 a year
- Posted
- Company
- University College London Hospitals NHS Foundation Trust
- Location
- London, United Kingdom W1T 7HA
- Employment Type
- Permanent
- Salary
- £58698.00 - £65095.00 a year
- Posted