Job summary
We are looking for a Senior Trial Coordinator to be responsible for a portfolio of local and national cancer clinical trials contributing to cancer research. Your day-to-day job will involve working closely with Trials Coordinators and Data Managers, and also liaising with medical staff, pharmacists and statisticians involved in oncology trials. You will interact closely with chiefs investigators and Sponsor, set-up clinical trials, line manage a small team and report on your trial portfolio. The post is currently funded for 1 year. The role requires at least 2 days in the office
Main duties of the job
To line manage and support the Clinical Trials Coordinators in their roles.To assist the portfolio manager in managing the research portfolio and workload of the coordination team.
To develop and provide a fast, effective and supportive service to researchers to ensure high quality research is conducted in the unit.
To ensure that all GCP requirements are met in the conduct and coordination of clinical studies.
To coordinate Trust-sponsored clinical research.
This post is essential to ensure appropriate resources and staff are in place for the set-up, conduct and close-down of the studies and compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, and its amendments, with the Good Clinical Practice Guidelines ICH-GCP/ E6(R2), the NHS Research Governance Framework for Health and Social Care, the Data Protection Act, the Human Tissue Act and other applicable UK legislation and guidelines.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 22nd May 2024.
Interviews are due to be held on the 13th June 2024.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 22nd May 2024.
Interviews are due to be held on the 13th June 2024.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Educated to Degree level in health-related or biomedical science or with equivalent experience.
Desirable
- Post grad degree in Clinical Trials, Epidemiology, study design or similar clinical trial related area.
Experience
Essential
- Significant experience of working in clinical resarch, including observational studies and Clinical Trials falling under the EU Directive of Clinical Trials within the NHS and/or University.
- Substantial experience in the set-up, protocol development, coordination and management of clinical trials.
- REC, MHRA, R&D submissions and report writing.
- Grant applications & grant costing.
- Setting timelines and milestones.
- Experience of line management.
- Experience in managing a portfolio of trials.
Desirable
- Experience of monitoring.
- Experience of document review.
- Experience of MHRA GCP Inspections and/or Sponsor Audits.
- Experience of leading meetings and informing best practices.
- Experience of developing new procedures and generating supporting SOPs.
- Experience of collaborating with the pharmaceutical industry in a clinical trial setting.
Knowledge
Essential
- Significant knowledge of UK regulations, guidelines and requirements for the conduct of clinical research.
- Good understanding of specific requirements for clinical trials, NHS research governance and NHS/UK approval processes.
- Knowledge of study and protocol design, case report form and database design, and pharmacovigilance requirements.
- Knowledge of data protection requirements.
Desirable
- Knowledge of Human Tissue act.
- Knowledge of Advanced Therapy Trials.
- IMP(GMP) and QP release.
Skills
Essential
- Excellent communication and interpersonal skills including the ability to build working relationships with department colleagues, Trust staff at all levels and external organisations such as the Ethics Committees, Universities, funding bodies, and other NHS Trusts.
- Excellent organisational and planning skills.
- Ability to work under pressure balancing conflicting workloads.
- Ability to work independently with initiative and maintain confidentiality.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Work with enthusiasm and demonstrate initiative.
- Maintain up to date knowledge of changes in research governance and legislation with the ability to disseminate information to relevant parties.
Person Specification
Qualifications
Essential
- Educated to Degree level in health-related or biomedical science or with equivalent experience.
Desirable
- Post grad degree in Clinical Trials, Epidemiology, study design or similar clinical trial related area.
Experience
Essential
- Significant experience of working in clinical resarch, including observational studies and Clinical Trials falling under the EU Directive of Clinical Trials within the NHS and/or University.
- Substantial experience in the set-up, protocol development, coordination and management of clinical trials.
- REC, MHRA, R&D submissions and report writing.
- Grant applications & grant costing.
- Setting timelines and milestones.
- Experience of line management.
- Experience in managing a portfolio of trials.
Desirable
- Experience of monitoring.
- Experience of document review.
- Experience of MHRA GCP Inspections and/or Sponsor Audits.
- Experience of leading meetings and informing best practices.
- Experience of developing new procedures and generating supporting SOPs.
- Experience of collaborating with the pharmaceutical industry in a clinical trial setting.
Knowledge
Essential
- Significant knowledge of UK regulations, guidelines and requirements for the conduct of clinical research.
- Good understanding of specific requirements for clinical trials, NHS research governance and NHS/UK approval processes.
- Knowledge of study and protocol design, case report form and database design, and pharmacovigilance requirements.
- Knowledge of data protection requirements.
Desirable
- Knowledge of Human Tissue act.
- Knowledge of Advanced Therapy Trials.
- IMP(GMP) and QP release.
Skills
Essential
- Excellent communication and interpersonal skills including the ability to build working relationships with department colleagues, Trust staff at all levels and external organisations such as the Ethics Committees, Universities, funding bodies, and other NHS Trusts.
- Excellent organisational and planning skills.
- Ability to work under pressure balancing conflicting workloads.
- Ability to work independently with initiative and maintain confidentiality.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Work with enthusiasm and demonstrate initiative.
- Maintain up to date knowledge of changes in research governance and legislation with the ability to disseminate information to relevant parties.
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
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital-Division R&D
Hills Road
Cambridge
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)