Job summary
We have an exciting opportunity for an experienced Clinical Trial Coordinator to join our friendly team.
This post is part of the Cambridge Eye Research Centre (CERC) at Cambridge University Hospitals NHS Foundation Trust. CERC caters for all Ophthalmology investigators of Cambridge University Health Partners (CUHP). This role is responsible for managing the CERC portfolio of clinical trials and projects.
The key job functions of the Clinical Trials Coordinator are:
- To facilitate and coordinate the set-up of trials conduct of clinical trials working closely with investigators and their teams.
- To develop and provide a fast, effective and supportive service to researchers wishing to collaborate with CERC to develop and run clinical studies and trials.
- To help manage the workload associated with the coordination of the CERC portfolio studies.
- To support a team of research ophthalmologists, research optometrists and research orthoptists in their roles to ensure that clinical studies and trials are conducted to a high quality standard.
To work in compliance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the NHS Research Governance Framework for Health & Social Care and, in the case of a CTIMP, in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004.
Main duties of the job
Main duties include: (Please see job description for full details).
- Management and coordination of day to day conduct of clinical trials/studies from set-up to close down within CERC in accordance with ICH GCP, NHS Research Governance and, for Clinical Trials of Investigational Medicinal Products (CTIMPs), the EU Directive on clinical trials.
- Provide training for new staff and lead on the development of all existing team members to ensure the department can maintain and grow its research facility.
- Manage the separate accounts associated with each research project, ensuring that all trials continue to be on budget. This will include escalating concerns to the PI/CI where funding issues are identified and providing solutions. Provide financial reporting to the PI.
- Coordinate multidisciplinary meetings and provide detailed minutes/logs.
- Track and schedule subject visits according to the research protocol and SOP's.
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 14th September 2023.
Interviews are due to be held on the 25th September 2023.
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 14th September 2023.
Interviews are due to be held on the 25th September 2023.
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
- Degree of professional qualification or equivalent level of knowledge and experience.
- Recent ICH GCP training.
Desirable
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Experience of working in a clinical research/ healthcare environment.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
- Experience with databases.
- Previous direct clinical trials and/or project management experience.
Desirable
- Experience of ophthalmology.
- Line management experience.
Knowledge
Essential
- Knowledge of the requirements of clinical trials during their life-cycle from set-up to close-out.
- Ability to present data in a clear, simple format.
- Ability to use Microsoft Office to an advanced level.
- Competence in using the internet and email.
- Knowledge of clinical trials regulatory framework.
Desirable
- Knowledge of clinical terms of ophthalmology.
- Clinical trials terminology and essential documentation.
- Study design.
- Knowledge of the clinical trials regulatory framework.
- An understanding of the clinical research approval process in the NHS.
Skills
Essential
- Excellent administrative skills including organising and planning.
- Excellent communication skills.
- Excellent attention to detail.
- Helpful, outgoing team worker.
- Excellent interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental and Trust colleagues.
- Ability to work under pressure, prioritise and seek input where necessary.
- Ability to work independently with initiative and motivate self and others.
- Ability to maintain confidentiality.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
Desirable
- Ophthalmology practical skills.
- Problem solver.
- Focused, starter-finisher.
- Willing to coach and train others.
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.
- Flexible approach to working and a desire to develop knowledge and career.
- Can demonstrate autonomous working practices in current passion.
- Willing to coach and train others.
- Ability to travel to participating sites to conduct on-site visits.
Person Specification
Qualifications
Essential
- Degree of professional qualification or equivalent level of knowledge and experience.
- Recent ICH GCP training.
Desirable
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Experience of working in a clinical research/ healthcare environment.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
- Experience with databases.
- Previous direct clinical trials and/or project management experience.
Desirable
- Experience of ophthalmology.
- Line management experience.
Knowledge
Essential
- Knowledge of the requirements of clinical trials during their life-cycle from set-up to close-out.
- Ability to present data in a clear, simple format.
- Ability to use Microsoft Office to an advanced level.
- Competence in using the internet and email.
- Knowledge of clinical trials regulatory framework.
Desirable
- Knowledge of clinical terms of ophthalmology.
- Clinical trials terminology and essential documentation.
- Study design.
- Knowledge of the clinical trials regulatory framework.
- An understanding of the clinical research approval process in the NHS.
Skills
Essential
- Excellent administrative skills including organising and planning.
- Excellent communication skills.
- Excellent attention to detail.
- Helpful, outgoing team worker.
- Excellent interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental and Trust colleagues.
- Ability to work under pressure, prioritise and seek input where necessary.
- Ability to work independently with initiative and motivate self and others.
- Ability to maintain confidentiality.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
Desirable
- Ophthalmology practical skills.
- Problem solver.
- Focused, starter-finisher.
- Willing to coach and train others.
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.
- Flexible approach to working and a desire to develop knowledge and career.
- Can demonstrate autonomous working practices in current passion.
- Willing to coach and train others.
- Ability to travel to participating sites to conduct on-site visits.
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).