Senior Staff Nurse

4 weeks ago

Sutton, United Kingdom The Royal Marsden Full time

Job overview

The Clinical Trials Monitor is a critical member of the Joint Clinical Research & Development Core Services (Good Clinical Practice and Regulatory Compliance team), sitting within The Royal Marsden’s Clinical Research Directorate. The role is responsible for the conduct of monitoring for single and multicentre clinical trials sponsored and/or managed by The Royal Marsden, from initiation to close-out, in compliance with the UK Clinical Trials Regulations. The role develops and maintains close working relationships with the clinical trial management team, and the research delivery teams across participating UK sites. 

Main duties of the job

Undertake monitoring visits in line with clinical trial monitoring plan. Prepare and disseminate monitoring reports, ensuring that issues are identified, recorded and resolved. Contribute to ensuring that, as far as possible, The Royal Marsden and the ICR remain ‘inspection ready’. Take a role in preparing both organisations for statutory MHRA inspections and will work towards positioning us as a leader in quality/compliance in cancer research. Act as an expert for The Royal Marsden and the ICR for information and advice regarding clinical trials monitoring, recommending system change and development, and sitting on relevant committees.

Detailed job description and main responsibilities

Gain knowledge of each clinical trial protocol including procedures and documentation in order to monitor the quality of the trial data, the safety of patient and accuracy of recording of the study in the case report forms and in the medical records Together with the clinical trial management team develop and keep updated the risk assessment and risk-based monitoring plans for all assigned clinical trials sponsored and/or managed by The Royal Marsden. Work with Trial Management Groups to identify systems for monitoring clinical trial activity at participating sites in accordance with all relevant regulations and SOPs / work instructions.

Person specification

Education/Qualifications

Essential criteria

Degree qualification (e.g., BSc) in a relevant subject or equivalent experience. Recognised Good Clinical Practice (GCP) certification Commitment to continued professional development.

Desirable criteria

Higher degree qualification (e.g., MSc) in a relevant subject.

Experience

Essential criteria

Prior experience of working as a clinical trial monitor (either in the academic or commercial sector) Experience of working to the UK Clinical Trials Regulations Experience of working in an NHS or HEI environment in a clinical research environment. Experience of working with staff from a range of backgrounds and different levels of seniority.

Desirable criteria

Experience of working across organisations. Experience of developing a strong culture of customer service. Experience of delivering training sessions

Skills / knowledge

Essential criteria

Proven ability to develop effective working relationships with staff at all levels. Detailed knowledge of UK Clinical Trials Regulations and GCP Able to summarise and explain complex issues to both technical and non-technical audiences Able to work in a proactive manner to identify new risks and issues and flag upwards appropriately Ability to deliver poor performance /non-compliance in a constructive manner Able to work under pressure, methodical in approach, with effective problem-solving ability. Excellent organisational skills Proficient IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams, and Access. Ability to develop new administrative systems to improve efficiency. Able to work constructively as an individual; as part of a closeknit team; and as part of a wider research community

Desirable criteria

Knowledge of systems and processes required to set-up and conduct clinical trials in the UK Knowledge of the management and conduct of oncology clinical trials

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

 As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.

Flu Vaccination – What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

Employer certification / accreditation badges

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