Job summary
Advert for Clinical Trials Coordinator Research and Innovation
Band 6 Clinical Trials Coordinator
We are looking to recruit a Clinical Trials Coordinator for the R&D Office in the Division of Research & Innovation at Great Ormond Street Hospital for Children NHS Trust. The key responsibility of the role is to conduct both onsite and remote monitoring for GOSH sponsored clinical trials.
The Clinical Trial Coordinator will work closely with the Clinical Trials Manager/s to ensure the sponsored trials are ICH GCP compliant. The studies vary from gene and cellular therapy trials to therapeutic drug trials from a range of clinical and academic specialties. The Clinical Trials Coordinator will work directly with Clinical Investigators, Pharmacy and Research Staff providing guidance and support for the management and monitoring of their trials. This will involve conducting trial monitoring and reporting from trial start to trial close, setting up trial master file, helping Clinical Trials Manager on sponsorship process, regulatory submissions, pharmacovigilance activities, and keeping up to date with changes in regulatory requirements related to clinical trials.
Main duties of the job
The post-holder will ensure that the clinical trial is being conducted in accordance with contractual agreements, trial protocol, trial-specific processes and systems, SOPs, regulatory and ethical requirements and ICH-GCP guidelines. They will also be the primary contact for the Investigator site staff, and ensure appropriate training is delivered and ongoing support through regular communication.
The successful applicantwill have a degree in a relevant subject or significant relevant experience, relevant experience in clinical trial monitoring and a strong editorial and critical proof reading skills are essential coupled with the ability to negotiate with professionals at all levels. A proven track record as a successful clinical researcher, ideally gained in the phase I/II clinical setting is desirable, with a strong working knowledge of Good Clinical Practice and navigating the various UK clinical research governance frameworks. You will need to be flexible, motivated, confident and creative and bring a new dimension to dealing with the management of clinical trials.
The post is likely to close early should appropriate number of applications as required by recruiter are received and appropriate candidates applications are received hence anyone applying should do so promptly to avoid any disappointment.
The post will be permanent and full time.
About us
Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is an international centre of excellence in child healthcare. GOSH is an acute specialist paediatric hospital with a mission to provide world-class care to children and young people with rare, complex and difficult-to-treat conditions.
Together with our research partner, the UCL Great Ormond Street Institute of Child Health, we form the UKs only academic Biomedical Research Centre specialising in paediatrics.
Most of the children we care for are referred from other hospitals throughout the UK and overseas. There are 60 nationally recognised clinical specialities at GOSH; the UK's widest range of specialist health services for children on one site.
We believe our people are the head, the heart, the hands and the face of GOSH. Being part of our team is incredibly rewarding and you will be doing something extraordinary to the lives of the children and young people we care for.
GOSH is a challenging, complex and inspiring place to work. Each and every day our people come together to support each other to deliver excellent patient care, often working to help our patients and their families navigate through demanding processes and difficult decisions.
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
Skills and Abilities
Essential
- Excellent communication and good presentation skills
- Good IT skills - including databases
- Excellent report writing skills
- Ability to prioritise workload and plan ahead
- Good Organisation and Negotiation skills
- 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
- Ability to coach and mentor senior academic staff including consultants
Knowledge & Experience
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
Desirable
- Understanding of pharmacovigilance
- Understanding of the NHS R&D structure and functions ; functions of clinical trial sponsor
- Good understanding of the Department of UK Policy framework for Health and Social Care Research
Education, Training and Qualifications
Essential
- A degree in nursing - or nursing equivalent to a first degree or a minimum of a first degree in a medical / biomedical subject
- ICH -GCP Certification
- Trial monitoring or auditor certification
Person Specification
Values
Essential
Skills and Abilities
Essential
- Excellent communication and good presentation skills
- Good IT skills - including databases
- Excellent report writing skills
- Ability to prioritise workload and plan ahead
- Good Organisation and Negotiation skills
- 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
- Ability to coach and mentor senior academic staff including consultants
Knowledge & Experience
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
Desirable
- Understanding of pharmacovigilance
- Understanding of the NHS R&D structure and functions ; functions of clinical trial sponsor
- Good understanding of the Department of UK Policy framework for Health and Social Care Research
Education, Training and Qualifications
Essential
- A degree in nursing - or nursing equivalent to a first degree or a minimum of a first degree in a medical / biomedical subject
- ICH -GCP Certification
- Trial monitoring or auditor certification
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).
