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Clinical Trials Associate/Coordinator

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University College London Hospitals NHS Foundation Trust

8d ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
    Healthcare
  • London

AI generated summary

  • You must manage trial setup, documentation, budgeting, act as a liaison, support investigators, engage in data management, and contribute to non-clinical study aspects.
  • You will set up trials, liaise with sponsors and investigators, handle documentation and approvals, manage budgets, support trial activities, and oversee data collection and reporting.

Requirements

  • Lead on the set-up of trials within the CRF with a single sponsor
  • To 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 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 relevant CRF staff and the JRO.
  • Act as the key and central 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.
  • Act as liaison between JRO, PI, sponsor and/or CRO to ensure that any queries are dealt with in a timely manner.
  • Execute SLA’s and reviews with support departments and other Trusts.
  • 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.
  • Contribute to all non-clinical aspects of conducting studies at site

Responsibilities

  • Lead on the set-up of trials within the CRF with a single sponsor
  • To 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 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 relevant CRF staff and the JRO.
  • Act as the key and central 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.
  • Act as liaison between JRO, PI, sponsor and/or CRO to ensure that any queries are dealt with in a timely manner.
  • Execute SLA’s and reviews with support departments and other Trusts.
  • 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.
  • Contribute to all non-clinical aspects of conducting studies at site

FAQs

What is the primary location for the Clinical Trials Coordinator position?

The primary location for the Clinical Trials Coordinator position is at the Leonard Wolfson Experimental Neurology Centre.

What will be the main responsibilities of the Clinical Trials Coordinator?

The main responsibilities include leading the set-up and implementation of commercial clinical trials, liaising with study teams and sponsors, processing amendments, maintaining databases, and ensuring regulatory aspects are upheld according to Good Clinical Practice standards.

Who will the Clinical Trials Coordinator liaise with during the trial process?

The Clinical Trials Coordinator will liaise with the study team, research team, investigators, study sponsors, the NIHR CRN: North Thames, and the Joint Research Office (JRO).

What types of trials will the Clinical Trials Coordinator be working on?

The Clinical Trials Coordinator will be working on a portfolio of trials from a single sponsor.

What kind of support will the Clinical Trials Coordinator provide to Principal and Chief Investigators?

The Clinical Trials Coordinator will support Principal and Chief Investigators throughout the clinical trial process, including assisting with Site Qualification and Initiation Visits, monitoring visits, and distributing essential trial paperwork.

Are there opportunities for professional development in this role?

Yes, working at UCLH provides opportunities for professional development within a renowned clinical research facility with a strong emphasis on education and world-class research.

How is UCLH recognized as a workplace?

UCLH has been voted as the #1 NHS Acute Trust to work for in the whole of England by its staff, reflecting a positive work environment and strong team ethos.

What core values are emphasized at UCLH?

UCLH emphasizes safety, kindness, teamwork, and continuous improvement as central values in their work culture.

How can I get in touch for more information about the role?

For further details or to arrange an informal visit, you can contact Claudia Ismail, the Senior Clinical Trials Coordinator, at Claudia.ismail@nhs.net.

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University College London Hospitals NHS Foundation Trust

UCLH provides first-class acute and specialist services in six hospitals in central London.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

University College London Hospitals (UCLH) NHS Foundation Trust is one of the UK's largest and most renowned healthcare providers. The Trust delivers high-quality patient care across a range of specialties, including cancer, neurology, women’s health, and emergency services. UCLH is committed to clinical excellence, research, and education, aiming to improve health outcomes through innovative treatments and world-class facilities. Their mission is to provide exceptional care and to advance medical knowledge for the benefit of patients and the wider community.