Clinical Research Quality Assurance Officer
5 months ago
The post-holder, as part of the GCP and Regulatory Compliance Team will support the Clinical Research Senior Quality Assurance Officer and the Clinical Research Quality Assurance Manager in developing and maintaining the Quality Management System (QMS) across The Royal Marsden and the Institute of Cancer Research, supporting sponsor oversight of clinical research risk, supporting management of serious breaches, and supporting CAPA implementation and quality improvement initiatives.
The post-holder will support the audit function within the GCP and Regulatory Compliance Team in delivering audits as part of the annual audit programme as required They will also contribute to the quality by design programme by contributing to the development of protocols for trials.
The post-holder will liaise with staff within The Royal Marsden and Institute of Cancer Research (ICR) staff, at all levels including senior medical, scientific, statistical, nursing and administrative staff. They will also liaise with the Chairman and members of the Committee for Clinical Research as well as external organisations within both the public and private sectors including Medicines & Healthcare Products Regulatory Agency and other regulatory bodies.
Support the writing of SOPs and guidance documents, and the development of templates and forms that ensure the implementation of GCP and relevant regulations.
Coordinate and manage the suite of research SOPs, ensuring that reviews are undertaken in a timely manner with wide representation.
Facilitate the activities of the RM/ICR Standard Operating Procedures Working Group (SOP-WG) and Standard Operating Procedure Oversight Group (SOP-OG).
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:
Facilitate the activities of the RM/ICR Risk Identification Group (RIG).
Coordinate input and update of the Joint Research Active Risk Log, ensuring that risk description, control and rating are reviewed with wide representation.
Ensure concordance of the Joint Research Active Risk Log pertinent to clinical research with the institutional risk logs of RM and ICR.
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