Clinical Trials Co-ordinator

Great Ormond Street Hospital for Children NHS Foundation Trust

20d ago

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

AI generated summary

You must support GCP compliance, assist with trial management, monitor adherence, and cooperate with regulatory bodies. Teamwork and commitment to diversity are essential.
You will assist with trial planning, ethics submissions, site monitoring, document verification, and ensure compliance with training and safety standards throughout the trial.

Requirements

Please do not apply if you have already applied for this post within the past 30 days
This post is based in the Research and Development (R&D) Office of Great Ormond Street Hospital (GOSH), Division of Research & Innovation and the Great Ormond Institute of Child Health (ICH), originally created in response to ‘The Medicines for Human Use (Clinical Trial) Regulations 2004’. The successful applicant will support and assist researchers in ensuring that GOSH/ICH is fully GCP compliant. The Clinical Trials Coordinator will work directly with Clinical Investigators, Pharmacy, and Research Staff providing guidance and administrative support for the management and monitoring of their trials. The position will also involve Interaction with the Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committee, Health Research Authority (HRA), Department of Health (DH), as well as other academic institutions essential to influence implementation of new requirements. A commitment to travel will be required for some multi centre trials.
There is a strong emphasis on team working to create systems for efficient support of the Division and researchers alike.
The role involves both trial monitoring and co-ordination of trials which include central monitoring and on site monitoring of trial conduct and adherence to protocol, SOPs, regulatory requirements and GCP.
Trial Start Up
To work with the Clinical Trials Manager to plan oversight activities and preparing the study documentation including Trial Master Files / Site Files and electronic R&D Files.
Assisting with Ethics and Regulatory submissions alongside the Clinical Trials Manager.
Undertaking site initiation visits and central monitoring to verify that the investigator and research team have adequate qualifications and resources and that these remain adequate throughout the trial period, that facilities, including laboratories, equipment and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
Ensuring trial teams have necessary essential documents and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirements.
To verify that the investigator’s trial staff are fully conversant with the protocol and are adequately trained to perform their allotted tasks.
To work alongside the clinical trial pharmacist to verify the investigational products before commencement of the trial and ensuring pharmacy sites have met sponsor requirements.
To identify monitoring risks and write monitoring plan for each trial and keep track of monitoring activities at all sites according to the plan. To review the plans in line with major protocol amendments and/or upon availability of any other safety information.
Trial Commencement
We are keen to make our workforce as diverse as the communities we serve, and we hope to attract applications from underrepresented groups, including people with Black, Asian and Minority Ethnic heritage, people with a disability, and people from LGBTQ+ communities. By growing an ever more diverse workforce, we’ll have a greater range of perspectives and knowledge, meaning that we can provide the children and young people at our hospital with even better care.
Our hospital is committed to creating an environment that is open and inclusive. Our staff are encouraged to engage with colleagues through the following networks: REACH (Race, Ethnicity and Cultural Heritage) ENABLED (Enhancing Abilities & Leveraging Disabilities Network), PRIDE and Women’s networks; all of which are sponsored by a member of our Executive Management Team.
We want to ensure that all of our people, regardless of their background, are seen and heard. We want to attract applicants that share our commitment to inclusion and that understand diversity is a strength that is embraced and valued.
For further details / informal visits contact: Name: Fahmida Hoque Job title: Clinical Trials Manager Email address: fahmida.hoque@gosh.nhs.uk Telephone number: 02074059200

Responsibilities

To work with the Clinical Trials Manager to plan oversight activities and preparing the study documentation including Trial Master Files / Site Files and electronic R&D Files.
Assisting with Ethics and Regulatory submissions alongside the Clinical Trials Manager.
Undertaking site initiation visits and central monitoring to verify that the investigator and research team have adequate qualifications and resources and that these remain adequate throughout the trial period, that facilities, including laboratories, equipment and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
Ensuring trial teams have necessary essential documents and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirements.
To verify that the investigator’s trial staff are fully conversant with the protocol and are adequately trained to perform their allotted tasks.
To work alongside the clinical trial pharmacist to verify the investigational products before commencement of the trial and ensuring pharmacy sites have met sponsor requirements.
To identify monitoring risks and write monitoring plan for each trial and keep track of monitoring activities at all sites according to the plan. To review the plans in line with major protocol amendments and/or upon availability of any other safety information.

FAQs

What qualifications are required for the Clinical Trials Coordinator position?

While the job description does not specify exact qualifications, applicants should have experience in clinical trials, knowledge of Good Clinical Practice (GCP), and be familiar with regulatory requirements.

Is prior experience in clinical trials necessary for this role?

Yes, previous experience in clinical trials and familiarity with regulatory compliance are essential for the Clinical Trials Coordinator position.

Will there be training provided for the role?

Yes, the successful applicant is expected to ensure that trial staff are adequately trained to perform their tasks, which implies ongoing support and training may be provided as part of the role.

Is travel required for this position?

Yes, a commitment to travel is required for some multi-centre trials.

How does the organization support diversity and inclusion?

The organization is committed to creating an open and inclusive environment and encourages applications from underrepresented groups. Various employee networks are available to promote engagement and support.

Who can I contact for informal inquiries about the position?

For informal visits or further details, you can contact Fahmida Hoque, the Clinical Trials Manager, via email at fahmida.hoque@gosh.nhs.uk or by calling 02074059200.

What are the main responsibilities of the Clinical Trials Coordinator?

The main responsibilities include supporting trial management and monitoring, ensuring GCP compliance, assisting with regulatory submissions, conducting site initiation visits, and creating monitoring plans for trials.

Are there specific organizations the Clinical Trials Coordinator will interact with?

Yes, the role involves interaction with various organizations, including the Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committee, and the Health Research Authority (HRA).

Is there a strong emphasis on teamwork in this role?

Yes, there is a strong emphasis on teamwork to create efficient systems that support both the Division and researchers.

Great Ormond Street Hospital for Children NHS Foundation Trust

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Mission & Purpose

Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is a national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK. It aspires to offer outcomes for children in the top five in the world. The largest centre in the UK for children with heart or brain problems, and, with UCLH it is the largest centre in Europe for children with cancer. It is the only specialist Biomedical Research Centre for paediatrics, it works in partnership with the UCL Institute of Child Health (ICH), part of University College London, and together they form the largest paediatric research and teaching centre in the UK, and one of the largest in the world. The hospital at Great Ormond Street is the only exclusively specialist children's hospital in the UK. It does not have an Accident and Emergency department and largely only accepts specialist referrals from other hospitals and community services. The population of children served by the hospital is characterised by those with multiple disabilities and/or health problems and rare and congenital (present at birth) conditions.