An opportunity has arisen at The Royal Marsden to work within the Haemato-Oncology Unit as a Senior Clinical Trial Coordinator, providing governance support for our complex research portfolio.
This is a pivotal role, and you will be part of a team of qualified and skilled medical and nursing staff, taking part in an exciting range of clinical research studies as well as having a key role supporting the administrative trial team.
Ideally with previous clinical research experience and NHS experience, you will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP.
Based at our Sutton location with occasional travel to our Chelsea location and some remote working, the successful applicant should have a flexible approach to their duties and the ability to work both as part of the team as well as independently. In addition, you will have excellent communication, administrative and IT skills and be supportive and open to new initiatives.
• To take responsibility for ensuring all clinical trials within the Unit are conducted and managed in accordance with Good Clinical Practice, Trust SOPs and trial protocols.
• To be a key member of the team responsible for conveying the requirements of the Clinical R&D Office to clinical staff within their allocated Clinical Unit.
• To provide an efficient clinical trial coordination service to the Unit Head, ensuring trials fulfil all statutory requirements.
• To oversee the conduct of trials within the Unit and maintain day-to-day responsibility for specific trials within the Unit.
• To represent the Unit at the Trial Coordination Forum.
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
For further information on this role, please see the attached detailed Job Description and Person Specification:
These responsibilities will be carried out under the guidance of the operations manager.
Service Delivery:
• Responsible for implementation of systems and processes within the Unit.
• Under the direction of the Operations Manager/Senior Trial Manger to lead in implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory requirements including:• Medicines for Human Use (Clinical Trials) Regulations
• Research Governance Framework for Health and Social Care
• Human Tissue Act
• To coordinate the portfolio research meeting ensuring appropriate, documented monitoring of the clinical trial portfolio
• To be a member of the Trial Coordination Forum
Trial Set Up and Maintenance
• Initiate and manage day to day running of allocated trial(s) in accordance with GCP and RMH / ICR SOPs, policies and procedures.
• Complete applications to REC, HRA, MHRA and CCR for new research proposals.
• Ensure trial does not commence until all regulatory, sponsor and local R&D requirements are satisfied.
• Ensure delegation logs are in place for trial and that these are kept up to date.
• Set up and maintain training records for staff working on the Trial.
Trial Conduct
• Responsible for ensuring all research within the clinical unit receives all relevant regulatory approval before it commences.
• Responsible for ensuring the Unit’s Clinical Research Portfolio is conducted in accordance with all regulatory requirements.
• To review capacity and resource requirements within the Clinical Unit for coordination and administrative management of trial portfolio and to advise the Unit Head accordingly.
• Ensure trials within the Unit are audit/inspection ready at all times.
• To be the Unit’s dedicated archivist for clinical trial records
Trial Closure
• Ensure trial closure is notified to Clinical R&D Office, Sponsor, REC, HRA and MHRA as appropriate
• Ensure appropriate archiving of trial documentation
• To liaise with pharmacy to ensure appropriate return or destruction of surplus IMP
• To notify Clinical R&D Office of study outcomes and publications relating to trial
• To ensure appropriate storage or destruction of human tissue following trial completion in accordance with written agreements, RMH / ICR SOPs and the Human Tissue Act.
This advert closes on Thursday 7 Dec 2023
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