About this role
Job summary
Full Time - 37.5 hours per week | Fixed Term - 12 months | Cross-site (Sutton and Chelsea)Agenda for Change Band 5
An exciting opportunity has arisen at The Royal Marsden Hospital for a Senior Clinical Trial Administrator within the Head, Neck and Thyroid Research Unit.
Working as part of a multidisciplinary team, you will support the delivery of a varied portfolio of clinical research studies. Previous clinical research experience is desirable, along with an understanding of clinical trial processes and Good Clinical Practice (GCP).
The successful candidate will be organised, adaptable and able to work independently and as part of a team. Excellent communication, administrative and IT skills are essential, together with a proactive approach and willingness to support service developments.
The Trust is committed to delivering excellent patient-focused care and expects all staff to treat patients, families, carers and colleagues with professionalism, respect and dignity.
Due to high application volumes, we reserve the right to close this vacancy early once sufficient applications have been received. Early applications are encouraged.
Only shortlisted candidates will be contacted. If you have not heard from us within two weeks of the closing date, please assume your application has been unsuccessful.
For further information, please contact Amy Scott, Clinical Research Operations Manager, at [email protected].
Main duties of the job
To support the clinical research team with study administration as required to ensure the efficient and successful delivery of clinical trials and other studies according to Good Clinical Practice (GCP), standard operating procedures (SOPs), trust policies and all applicable regulations and governance structures.
To ensure timely and accurate entry of data and relevant information into appropriate database systems
To work with the clinical team to ensure prompt resolution of data queries
Responsibility for the day-to-day supervision, training and oversight of workload for the Clinical Trial Administrators (CTAs) to ensure data management is performed to required standards to meet all relevant SOPs and regulations. To be an active member of the department, providing regular reports on data activity within the unit and highlighting areas of concern. Management of a small portfolio of low risk studies in the unit (if applicable).
About us
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.
Job description Job responsibilities
For further information please refer to the job description and personal specification
Primary areas of responsibility:
To ensure that data collection and (electronic) case report form ((e)CRF) completion is performed to the required standards of the current EU, UK and FDA legislation, Trust SOPs and Sponsor contractual obligations.
To regularly report on data entry status to ensure deadlines are met for interim and final analysis
Ensure that scans are uploaded to trial specific electronic portals where required.
Tissue tracking using RMH systems (as applicable)
To design and implement tools and guidance for clinical trial data capture.
To prepare and facilitate the archiving of essential clinical trial documents and source data as per Trust SOPs.
To undertake projects with relation to office management as required.
To represent the Data Management team at research meetings
Responsible for daily supervision and leadership of the department CTAs working to improve service and efficiency with the context of the research team.
To ensure workload is distributed appropriately across the trial administration team.
To encourage the CTAs to develop their knowledge and experience on an ongoing basis.
To complete regular performance reviews of the CTAs in conjunction with the line manager and liaise regularly with the line manager to take action if performance is below standard.
To ensure the CTAs review and adhere to Trust SOPs relating to their role.
To provide reports on data entry status across the clinical trial portfolio, ensuring deadlines are met for interim and final analyses.
To lead on audit and inspection preparation with the data management team of CTAs.
Person Specification
Education/Qualifications Essential
Educated to at least GCSE/A level (or equivalent) Knowledge of ICH/GCP guidelines
Experience Essential
Good understanding of medical terminology Previous experience of working in the NHS or equivalent Experience in working with databases
Skills/Abilities/Knowledge Essential
Excellent administrative and organisational skills Competence in research orientated PC software including Microsoft Office packages Excellent oral and written communication skills Good attention to detail Understanding of clinical trials and regulations governing clinical research Experience of data entry and data management Good level of spoken and written English
Other Requirements Essential
Ability to support and train team members Able to work on both sites and to be flexible to meet the needs of the role
Desirable
Willingness to travel within UK and occasionally overseas to attend meetingsand conferences
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details Employer name The Royal Marsden NHS Foundation Trust
Address The Royal Marsden - Chelsea
Chelsea
SW3 6JJ
United Kingdom
Employer's website https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)