Clinical Trial Coordinator

3 weeks ago

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

An excellent opportunity has arisen at The Royal Marsden Hospital to work within the Head, Neck and Thyroid Research Unit as a Clinical Trial Coordinator.

This is a pivotal role and you will be part of a multidisciplinary team including experienced medical and nursing staff, taking part in an exciting range of clinical research studies.

Ideally with previous clinical research experience and preferably educated to degree level, 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 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.

The Trust is committed to developing and delivering excellent customer focused service by treating patients, their families, friends, carers and staff with professionalism respect and dignity.

Responsible for the day-to-day coordination and oversight of allocated clinical trials in the Department.

Responsible for the set-up and conduct of allocated clinical trials in accordance with regulatory, sponsor and organisational requirements. Ensure clinical trials within the Unit are conducted in accordance with Good Clinical Practice and Trust SOPs.
Review the capacity and resource requirements within the Clinical unit for coordination and administrative management of the allocated trials and to advise the unit head accordingly.

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

**Primary areas of responsibility**:
Trial set-up
- To liaise with R&D, pharmacy, finance, laboratories, and other support departments in set up of trials and assessment of capacity and capability.
- To liaise with Sponsors and R&D regarding clinical trial contracts.
- 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 [including training and delegation logs] compilation and maintenance of site files.

Trial conduct
- 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).
- Ensure trial specific responsibilities delegated by the Sponsor to the Chief Investigator (CI) / Principal Investigator (PI) are carried out in accordance with sponsor contract.
- Prepare and submit amendments to R&D.
- Ensure the team is kept regularly informed on the progress of trials.
- Coordinate relevant reports to the appropriate bodies.
- Collaborate with Research Nurses and other clinical staff for reporting and updating Serious Adverse Events (SAEs).
- Input and update patients on CCRPAT.
- Ensure timely raising of invoices for externally funded clinical trials.
- To facilitate monitoring and audit of the Unit’s clinical trials by external commercial and non-commercial sponsors, including the use of remote systems.
- Assist with data entry and query resolution when applicable.

Trial closure
- To ensure trial closure is notified to R&D.
- Assist in conducting the Trial Close Out visit and associated tasks.
- To ensure appropriate archiving of trial documentation.

Communication & networking
- Act as a point of contact for trial

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