Clinical Trials Associate/Coordinator

University College London Hospital; City Of London; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading healthcare institution is seeking a Clinical Trials Coordinator to lead on the setup and implementation of commercial clinical trials. You will liaise with various stakeholders and ensure trials meet regulatory standards. This role requires significant experience in clinical trials and a degree in a related field. A commitment to flexibility in working practices is essential.

Benefits

Flexible working

Wellbeing programs

Travel loans

Qualifications

• Comprehensive understanding of UK Clinical Trials Regulations.
• Excellent knowledge of Good Clinical Practice (GCP).
• Significant experience in a clinical trials setting.

Responsibilities

• Lead set-up and implementation of clinical trials.
• Maintain study information databases.
• Assist with project costings and monitor trial grants.

Skills

Administrative skills

Organizational skills

Communication

IT skills

Education

First degree in scientific/healthcare related discipline

Job description

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) in Queen Square. We are looking to recruit a self-motivated and enthusiastic Clinical Trials Coordinator (CTC) to lead on the set-up and implementation of commercial 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 process amendments and play a key role in maintaining study information on databases to reflect CRF activity. The regulatory aspects of clinical trials must be maintained to Good Clinical Practice (GCP) standards. The post holder will be based primarily at the Leonard Wolfson Experimental Neurology Centre and will work on a portfolio dedicated to a single sponsor, supporting all aspects of non-clinical coordination, data collection, data reporting and finances. This is an all-encompassing role, including support from study start-up to close-out.

Main duties of the job

• Lead on the set-up of trials within the CRF with a single sponsor
• Be the point of contact for the sponsor, research team, investigators
• Prepare documentation and apply for ethics, Competent Authority and HRA approvals, local feasibility, assess requirements, arrange and confirm requirements, and NIHR CRN adoption including substantial amendments as required
• 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 CRF staff and the JRO
• Act as the central point of contact for trial-specific queries and support trial Principal Investigators and Chief Investigators throughout the clinical trial process, including Site Qualification and Initiation Visits, monitoring visits, and distributing essential trial paperwork
• Act as liaison between JRO, PI, sponsor and/or CRO to ensure timely handling of queries
• Execute SLAs and reviews with support departments and other Trusts
• Oversee and actively engage in data collection, data entry/management, statistical analysis, report writing and trial archiving as required
• Contribute to non-clinical aspects of conducting studies at site

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, 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, including University College Hospital, the National Hospital for Neurology and Neurosurgery, and several others. UCLH specialises in women’s health, cancer, infection, neurological, gastrointestinal and oral disease, with world-class support services.

At UCLH we have a real ‘One Team’ ethos, and our values — safety, kindness, teamwork and improving — are central to the way we work, as recognised by staff who voted UCLH the #1 NHS Acute Trust to work for in England.

Detailed job description and main 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 recognises the benefits of flexible working for staff. To find out more, visit: Flexible working.

To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?

Person specification

Knowledge and Qualifications

Essential criteria

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

Desirable criteria

• Excellent working knowledge of EU pharmacovigilance requirements

Experience

Essential criteria

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

Skills and Abilities

Essential criteria

• Excellent administrative and organisational skills
• Ability to prepare reports
• Resourceful and able to act on own initiative with appropriate guidance from line manager
• Flexible and supportive approach to teamwork, with a proactive approach to developing and documenting systems and procedures
• Outstanding organisational skills, managing multiple time-pressured projects with ability to prioritise
• Ability to summarise scientific data/information
• Adherence to written procedures
• Commitment to keeping up to date with current and new research legislation and willingness to undertake further training
• Willingness to undertake relevant training
• Excellent IT skills (Word, Excel, PowerPoint, Access/databases, Internet/Email)

Communication

Essential criteria

• Ability to write in a scientific, concise, technical and cohesive manner
• Proven ability to communicate effectively verbally

Personal and People Development

Essential criteria

• Demonstrates ability to lead and mentor

Desirable criteria

• Demonstrates coaching skills

Equality, Diversity and Inclusion

Essential criteria

• Demonstrates willingness to treat others with dignity and compassion. Values diversity and fairness. Understands the Equality Act 2010, duties, roles and responsibilities.

Specific Requirements

Essential criteria

• Good eye for detail

UCLH is committed to equality of opportunity and being a diverse and inclusive employer. Applications are encouraged from candidates of all backgrounds and perspectives to support world-class research and service delivery. UCLH offers flexible working and a range of staff benefits, including travel loans, wellbeing programs, and discounts.

This vacancy may close before the listed closing date; please submit your application promptly.

All correspondence regarding your application will be via email through TRAC.jobs. Please check your inbox regularly.

For further support on submitting an application please refer to the NLPSS Applicant Toolkit: https://royalfree.pagetiger.com/cuuomnr/1

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Documents to download

• Job Description (PDF, 576.3KB)
• Functional Requirements (PDF, 262.3KB)
• UCLH Values (PDF, 860.9KB)