Job summary
An exciting opportunity has arisen for a Clinical Trial Administrator to join the Breast Clinical Research Unit at The Royal Marsden NHS Foundation Trust, based mainly at our Chelsea site.The Royal Marsden is a world leader in cancer research, treatment and education. Together with our academic partner, The Institute of Cancer Research (ICR), we are the largest comprehensive cancer centre in Europe and the only National Institute of Health Research (NIHR) Biomedical Research Centre (BRC) specialising in cancer in the UK.
We are looking for enthusiastic and self-motivated team members to contribute to the ground-breaking research run out of this unit.
The purpose of the role is:oTo support the Breast Research Governance team with study administration in order 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.
oTo provide timely and accurate data entry and query resolution into the appropriate database.
Continuous professional development is encouraged. Working as a highly valued member of the MDT, we support further study opportunities.
Main duties of the job
To provide timely and accurate data entry and query resolution into the appropriate trial database (eCRF).
To support the Breast Research Governance team with study administration in order 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.
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 and learning and development opportunities. 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 on this role, please see the attached detailed Job Description and Person Specification.
Primary areas of responsibility
To ensure trial data is entered into the appropriate databases and systems, and to ensure all queries are resolved in a timely mannerTo support the Clinical Research Operations Manager (CROM) with unit administration.To provide administrative and data management support for the Research Portfolio.To ensure that data collection and CRF completion is performed to the required standards of the current EU, UK and FDA legislation and RMH SOPs.
Communication & Networking
Liaise with external agencies (e.g. Sponsor organisations, R&D Departments and Local Ethics Committees etc) on behalf of Research Nurses/Trials Coordinators/CROM where required.Act as a point of contact for trial sponsors and communicate with them directly regarding data queries, monitoring visits and other enquiries relevant to the trial and research team.Communicate with staff at all levels, both internal and external relating to trial activities, regarding information which may be confidential and sensitive in nature.Liaise with diagnostic departments within the hospital about all queries relating to tests/scans.Ensure that scans and response assessments are reproduced in a timely manner for the purposes of the clinical trial and that they are dispatched according to study protocol.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification.
Primary areas of responsibility
To ensure trial data is entered into the appropriate databases and systems, and to ensure all queries are resolved in a timely mannerTo support the Clinical Research Operations Manager (CROM) with unit administration.To provide administrative and data management support for the Research Portfolio.To ensure that data collection and CRF completion is performed to the required standards of the current EU, UK and FDA legislation and RMH SOPs.
Communication & Networking
Liaise with external agencies (e.g. Sponsor organisations, R&D Departments and Local Ethics Committees etc) on behalf of Research Nurses/Trials Coordinators/CROM where required.Act as a point of contact for trial sponsors and communicate with them directly regarding data queries, monitoring visits and other enquiries relevant to the trial and research team.Communicate with staff at all levels, both internal and external relating to trial activities, regarding information which may be confidential and sensitive in nature.Liaise with diagnostic departments within the hospital about all queries relating to tests/scans.Ensure that scans and response assessments are reproduced in a timely manner for the purposes of the clinical trial and that they are dispatched according to study protocol.
Person Specification
Education/Qualifications
Essential
- Educated to at least GCSE/A level (or equivalent)
Desirable
- Knowledge of ICH/GCP guidelines
Experience
Desirable
- 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
- Excellent knowledge of Microsoft Office applications, in particular Microsoft Excel
- Excellent oral and written communication skills
- Excellent attention to detail
- Ability to maintain excellent interpersonal & communication skills with a wide range of people (e.g., medical & nursing staff, managers and pharmaceutical industry representatives)
Desirable
- Understanding of clinical trials and regulations governing clinical research
- Ability to grasp new concepts quickly
Person Specification
Education/Qualifications
Essential
- Educated to at least GCSE/A level (or equivalent)
Desirable
- Knowledge of ICH/GCP guidelines
Experience
Desirable
- 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
- Excellent knowledge of Microsoft Office applications, in particular Microsoft Excel
- Excellent oral and written communication skills
- Excellent attention to detail
- Ability to maintain excellent interpersonal & communication skills with a wide range of people (e.g., medical & nursing staff, managers and pharmaceutical industry representatives)
Desirable
- Understanding of clinical trials and regulations governing clinical research
- Ability to grasp new concepts quickly
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
