Clinical Trial Coordinator

4 months ago

Chelsea, United Kingdom The Royal Marsden NHS Foundation Trust Full time

An opportunity has arisen at The Royal Marsden to work within the Renal, Skin and Melanoma Research Unit as a Clinical Trials Coordinator.

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 as line manager to 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.

The post is based across our London and Sutton location, 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.
- Responsibility for the day to day coordination and oversight of specific hosted and some sponsored clinical trials in the Department.
- Lead on the set-up of specific clinical trials in accordance with regulatory, sponsor and organisational requirements.
- To be an active member of the department, providing regular reports on activity within the Department and highlighting areas of concern.

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, please refer to the Job Description/Person Specification

Trial set-up
- Initiate and manage day to day running of allocated trial(s) in accordance with Good Clinical Practice (GCP) and The Royal Marsden (RM) / Institute of Cancer Research (ICR) Standard Operating Procedures (SOPs)
- To ensure trials do not commence until all regulatory, sponsor and local R&D requirements are satisfied
- Ensure delegation logs are in place for trials and that these are kept up to date
- Set up and maintain training records as appropriate for staff working on trials
- To liaise with commercial companies and other funders to establish funding and sponsor contracts for trials and to ensure adequate drug supply for the duration of the trials
- To liaise with R&D to ensure appropriate material transfer arrangements are in place for trials involving transfer or receipt of tissue
- Responsible for essential trial documentation compilation and maintenance in Trial Master Files / Trial Site Files
- To liaise with R&D, pharmacy, finance, laboratories and other support departments in set up of trials
- To be the main point of contact for setting up participating sites in multi centre studies

Trial conduct
- Ensure trial conducted in accordance with GCP and RMH / ICR SOPs
- Ensure trial specific responsibilities delegated by the Sponsor to the Chief Investigator (CI) / Principal Investigator (PI) are carried out in accordance with sponsor contract
- Update trial documentation as necessary e.g. protocols, investigators brochures, case report forms and patient information sheets
- Prepare and submit amendments under the guidance of the CI / PI for regulatory approvals as appropriate
- Ensure the CI / PI is kept regularly informed on the progress of trials
- As a member of the multi-disciplinary team (MDT) ensure recruitment of patient to a trial is carried out appropriately. This will include:

- Ensure informed consent procedures are followed by the clinical staff
- Ensure all patients screened and randomised are recorded on appropriate systems/logs
- Randomisation of patients to trials where appropriate
- Maintain, manage and follow timely and efficient procedures for collection, computer entry and verification for patient data
- Responsible in collaboration with t

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