Job overview
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.
Main duties of the job
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
To undertake site monitoring visits/central monitoring (as required) for the trial throughout its duration according to Sponsor’s SOP:
• To verify that the investigator/research team follows the approved protocol and all approved amendment(s) if any.
• To verify that the investigator and the investigator’s trial staff are performing the specified trial functions, in accordance with the protocol, the written agreement(s) between the sponsor and the investigator/institution, the trial procedures manual (if present), the trial delegation log and have not delegated these functions to unauthorised individuals.
• To verify that the investigator is enrolling only eligible subjects.
• To verify that written informed consent was obtained before each subject’s participation in the trial.
• To verify that the Investigator’s Trial Master File, source documents and other trial records are accurate, complete, kept up-to-date and maintained.
• To monitor the pharmacy files, drug accountability including gene therapy batch records as required.
• To review source data and check the accuracy and completeness of entries on the Case Report Forms (CRFs), source documents and other trial-related records against each other and inform sites of any CRF entry error, omission, or illegibility.
• To determine whether all serious adverse events (SAEs) are appropriately reported in accordance with the protocol, the Ethics Committee, the sponsor’s requirements and the applicable regulatory requirement(s.) Liaise and refer any issues to the Clinical Trials Manager or Head of Governance, Clinical Trials and Contracts.
• To communicate deviations from the protocol, Standard Operating Procedures (SOPs), GCP and the appropriate regulatory requirement(s) to the investigator and trial team members, taking appropriate action designed to prevent recurrence of the detected deviations.
• To document the monitoring visit and follow-up the investigator’s implementation of the actions and recommendations listed in the monitoring report with the Clinical Trials team.
To assist Clinical Trials Manager in overseeing pharmacovigilance process as and when required.
Trial Close-Out
• Ensure all unused trial supplies are accounted for and to liaise with pharmacy over any destruction that may need to take place.
• Close down the centres on completion of the trial.
• Assist with archiving of trial documentation with the UCL or GOSH archiving facility
• Prepare final close-out reports with the clinical teams
Audit and Inspections
• In the event of a statutory inspection (MHRA) for GCP, contribute to and participate in the preparation for the inspection, including contributing to the dossier, training of staff and researchers during the inspection and follow up work.
• To assist the Clinical Trials Manager and senior management in preparing for statutory inspections (MHRA) for pharmacovigilance
• Work with RM&G Officers to conduct audits of hosted clinical trials to ensure UK policy framework for Health and Social Care Research and Regulatory compliance.
As a member of the Joint R&D Office the post holder will be expected to contribute to its continued development:
• Collaborate with other members of the Office in the development, testing and validation of systems, standard documents and flow charts to assist in the daily business of the R&D Office.
• Support an atmosphere of team spirit and commitment to provide high quality, professional, efficient service and support.
• Contribute to the provision and updating of Standard Operating Procedures, Guides and Templates, relevant to monitoring and GCP.
• Develop an increased understanding of Pharmacovigilance and safety issues and contribute to a culture of embedding Pharmacovigilance in the clinical trial teams
• Keep up-to-date on any new developments affecting regulations or clinical research.
• To be responsible for arranging, coordinating, managing and reporting GOSH local genetically modified organism safety committee.
This job description is intended as an outline of the areas of activity and can be amended in the light of the changing needs of the service and will be reviewed as necessary in conjunction with the post-holder.
The post holder will carry out other duties as are within the scope, spirit and purpose of the job description as requested by the Clinical Trials Manager.
Working for our organisation
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.
Detailed job description and main responsibilities
Please refer to the Job description for full details of the job description for the main responsibilities.
Person specification
Values
Essential criteria
* Gosh Values
* Knowledge and understanding of diverse backgrounds and perspectives.
* Understanding of Diversity and Inclusion challenges in the workplace.
* Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Academic/Professional qualification/Training
Essential criteria
* A degree in science – or equivalent to a first degree or a minimum of a first degree in a medical / biomedical subject
* ICH –GCP Certification
Desirable criteria
* Trial monitoring or auditor certification
Trial monitoring or auditor certification
Essential criteria
* Good knowledge and understanding of the UK legislation for clinical trials of medicinal products and GCP
* Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or a university.
* Either practical experience of monitoring /auditing clinical trial activity or practical experience of the research process or direct involvement in the management / administration of clinical trials
* Understanding of the NHS R&D structure and functions: functions of clinical trial sponsor
Desirable criteria
* Understanding of pharmacovigilance
* Good understanding of the Department of Health’s UK Policy framework for Health and Social Care Research
Skills/Abilities
Essential criteria
* Excellent communication and good presentation skills
* Good IT skills - including databases
* Excellent report writing skills
* Good Organisation and Negotiation skills
* Ability to prioritise workload and plan ahead
* Self-motivated, with ability to work on own initiative, making decisions where appropriate
* Flexible working approach and adaptable to change.
* Commitment to team-working
* Ability to persevere and be proactive
* Ability to coach and mentor senior academic staff including consultants