Senior Clinical Trial Coordinator

Job overview

.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.

• 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.

Detailed job description and main responsibilities

Primary areas of responsibility 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: o Medicines for Human Use (Clinical Trials) Regulations o Research Governance Framework for Health and Social Care o 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 Unit’s 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 Unit’s 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.