Clinical Trials Associate/Coordinator

Current vacancies

Site: NIHR UCLH Clinical Research Facility
Town: London
Salary: £44,806 - £53,134 Per annum inclusive of HCAS
Salary period: Yearly
Closing: 26/02/:59

The use of AI is monitored, and if applicants have used it, then they are required to declare this in their supporting statement.

Job overview

The NIHR UCLH Clinical Research Facility is a well-established Clinical Research Facility covering two sites: a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at 170 Tottenham Court Road, and the Leonard Wolfson Experimental Neurology Centre at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS).

We are looking to recruit a self-motivated and enthusiastic Clinical Trials Coordinator (CTC) to work in the CRF. The CTC will be responsible for leading on the set-up and implementation of commercial and academic clinical trials, liaising with study teams, service departments, study sponsors, the NIHR CRN: North Thames, and the Joint Research Office (JRO) to ensure trials are set up in a timely manner and run efficiently at the CRF. The post holder will also process amendments and will have a key role in ensuring that study information is maintained on databases to accurately reflect CRF activity, while ensuring the regulatory aspects of clinical trials are maintained to Good Clinical Practice (GCP) standards.

The post holder will be based across both CRF sites according to the needs and requirements of the busy and dynamic study portfolio.

Main duties of the job

1. Lead on the set-up of trials within the CRF across a variety of specialties and an expanding portfolio.
2. Prepare documentation and apply for ethics, Competent Authority and HRA approvals, local feasibility, Assess Arrange and Confirm requirements, and NIHR CRN adoption including substantial amendments, as required.
3. Assist with project costings at the proposal stage, monitor trial grants, review expenditure against budget and ensure adherence to terms of all relevant contracts, in collaboration with relevant CRF staff and the JRO.
4. Act as the key point of contact for trial-specific queries, and support trial Principal and Chief Investigators throughout the clinical trial process, including supporting Site Qualification and Initiation Visits as needed, monitoring visits, collating and distributing essential trial paperwork, and other tasks related to trial progress at all stages of the trial life-cycle.
5. Act as liaison between JRO, PI, sponsor and/or CRO to ensure that any queries are dealt with in a timely manner.
6. Execute SLA's and reviews with support departments and other Trusts.
7. Oversee, facilitate and actively engage in data collection, data entry/management, statistical analysis, report writing, and trial archiving activities - contributing directly to those activities as required.

Working for our organisation

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, throughout the UK 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:

• University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
• National Hospital for Neurology and Neurosurgery
• Royal National ENT and Eastman Dental Hospitals
• University College Hospital Grafton Way Building
• Royal London Hospital for Integrated Medicine
• University College Hospital Macmillan Cancer Centre
• The Hospital for Tropical Diseases
• University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specializes 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.

Person specification Knowledge and Qualifications

• First degree in scientific/healthcare related discipline or equivalent experience.
• Comprehensive understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials, and the UK Policy Framework for Health and Social Care Research.
• Familiar with the regulatory processes in the UK required for authorising, conducting, and terminating clinical research.
• Excellent working knowledge of Good Clinical Practice (GCP) and good knowledge and understanding of other related standards such as Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP).
• Excellent working knowledge of EU pharmacovigilance requirements.

Experience

• Significant experience of working in a clinical trials setting.
• Experience of setting up commercial and non-commercial clinical trials.
• Experience of working in a pharmaceutical company, contract research organisation, academic clinical trials unit or similar organisation.
• Experience of preparing regulatory and ethics submissions, writing/amending protocols, Participant Information Sheets, case report forms, and other relevant trial management documentation.

Skills and Abilities

• Excellent administrative and organisational skills.
• Ability to prepare reports; resourceful and able to act on own initiative, checking with the line manager when appropriate.
• Flexible and supportive approach to team working, and a proactive approach to develop and document systems and procedures.
• Outstanding organisational skills, managing several projects that are often time pressured, concurrently.
• Ability to summarise scientific data/information.
• Ability to maintain adherence to written procedures.
• Keen to remain up to date with current and new research legislation and guidance and willing to undertake further training related to this as required.
• A willingness to undertake further training as necessary and relevant to meet the needs of the department/team.
• Excellent IT skills, including Word, Excel, PowerPoint, Access/databases, and the Internet/email.

Communication

• Ability to write in a scientific, concise, technical and cohesive manner.

Personal and People Development

• Demonstrates ability to lead and mentor.
• Demonstrates coaching skills.

Responsibilities towards promoting Equality, Diversity and Inclusion

• Demonstrates willingness to treat others with dignity and compassion. Places a high value on diversity and fairness. Understands the Equality Act 2010, duties, roles, and responsibilities.

Other requirements

At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork, and improving - are central to the way we work. This is supported by our staff, who voted us as the NHS Acute Trust to work for in England.

At UCLH we take equality of opportunity seriously and are committed to being a diverse and inclusive employer, with a culture that creates a real sense of belonging and trust. It is our fundamental aim to recruit, retain, and promote a diverse mix of people who are representative of our local communities. Applications are encouraged from candidates of all backgrounds, cultures, and perspectives to support our world-class research, innovation, and creativity.

This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.