Job summary
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
o 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.
o 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.o 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.o To verify that the investigator's trial staff are fully conversant with the protocol and are adequately trained to perform their allotted tasks.o 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.o 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
About us
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.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Person Specification
Values
Essential
- 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
- 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
- Trial monitoring or auditor certification
Trial monitoring or auditor certification
Essential
- 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
- Understanding of pharmacovigilance
- Good understanding of the Department of Health's UK Policy framework for Health and Social Care Research
Skills/Abilities
Essential
- 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
Person Specification
Values
Essential
- 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
- 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
- Trial monitoring or auditor certification
Trial monitoring or auditor certification
Essential
- 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
- Understanding of pharmacovigilance
- Good understanding of the Department of Health's UK Policy framework for Health and Social Care Research
Skills/Abilities
Essential
- 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
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
UCL Institute of Child Health
30 Guildford Street
London
WC1N 1EH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
