About this role
Job summary
.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.
Main duties of the job
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.o 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.o To provide an efficient clinical trial coordination service to the Unit Head, ensuring trials fulfil all statutory requirements.o To oversee the conduct of trials within the Unit and maintain day-to-day responsibility for specific trials within the Unit.o To represent the Unit at the Trial Coordination Forum.
About us
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.
Job description Job responsibilities For further information please refer to the job description and personal specification
Primary areas of responsibilityThese 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:o Medicines for Human Use (Clinical Trials) Regulationso Research Governance Framework for Health and Social Careo 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.
To supervise other clinical trial coordinators and clinical trial administrators within the Unit as appropriate.
Coordination of specific trials allocated to the Coordinator within the Units portfolio. 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.
Trial Conduct
Responsible for ensuring all research within the clinical unit receives all relevant regulatory approval before it commences.
Responsible for ensuring the Units Clinical Research Portfolio is conducted in accordance with all regulatory requirements.
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.
Person Specification
Education/Qualifications Essential
Recent GCP training Life Sciences (or equivalent) degree or relevant experience
Experience/Knowledge Essential
Demonstrable experience of working in a clinical trial setting Understanding of clinical trials and regulations governing clinical research
Desirable
Experience of trial set up/management experience in an academic institution/hospital Experience of working in the field of haematology/oncology
Skills/Abilities Essential
Ability to prioritise workload and adjust own work in light of unexpected events or changing priorities. To be able to use own initiative planning own work and work unsupervised where appropriate. Excellent administrative and organisational skills Excellent IT skills including access, excel and power point Experience of data entry and data management Excellent oral and written communication skills Ability to interact with, influence an motivate people at all levels Ability to interact confidently with experts and non-experts alike Good attention to detail Ability to maintain adherence to written procedures Experience of problem solving
Desirable
Experience of supervising administrative staff
Other Requirements Essential
Able to work on both sites and to be flexible to meet the needs of the role
Desirable
Willingness to travel within the UK and occasionally overseas to attend meetings and conferences
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.
Employer details Employer name The Royal Marsden NHS Foundation Trust
Address Royal Marsden Hospital Sutton
Sutton
SM2 5PT
United Kingdom
Employer's website https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)