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
