Job summary
We are looking for a Clinical Trial Coordinator to be part of the well-established Cancer Theme of the Cambridge Clinical Trials Unit. This is a non-patient facing position, requiring a candidate with clinical trials and/or project management experience.
You will have primary responsibility for coordinating a multicentre clinical trial of an investigational medicinal product (CTIMP) in the urological malignancies field.
Your day to day job will involve working closely with data managers, laboratory staff, statisticians and programmers, but also to liaise with medical staff involved in oncology trials and monitor the conduct of the studies. You will interact with regulatory authorities and collaborators, produce reports to stakeholders, and work in accordance with nationally agreed standards. This post is funded for 1 year, in the first instance, with the potential for contract renewal, dependent upon funding.
The job is a hybrid role, involving mandatory office presence in Cambridge of at least 2 days a week. Interviews are expected to take place w/c 8th January 2025 and will be face-to-face in Cambridge.
Main duties of the job
Coordinate the setup and conduct of clinical trials and/or clinical studies working closely with the chief investigators and their teams.
Setup participating sites in multi-centre trials and ensuring that all data and samples are collected following the protocol.
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.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 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.
Please note:- Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close at midnight on 1st January 2025
Interviews are due to be held on 8th January 2025
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
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.
Please note:- Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close at midnight on 1st January 2025
Interviews are due to be held on 8th January 2025
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
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
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Significant experience of working in clinical research, 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 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 department 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
- 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 post.
- Ability to travel to participating sites to conduct on-site visits.
Person Specification
Qualifications
Essential
- Educated to Degree level in health-related or biomedical science or with equivalent experience.
Desirable
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Significant experience of working in clinical research, 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 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 department 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
- 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 post.
- 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).