Job summary
The post holder will provide support to the Research Operational Manager and the wider research team. You will support the clinical research team with the administrative and data management including data entry in accordance to GCP, and The Royal Marsden standard operating procedures (SOPs).
Main duties of the job
o 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.o To ensure timely and accurate entry of data and relevant information into appropriate database systemso To work with the clinical team to ensure prompt resolution of data querieso To be an active member of the department, providing regular reports on data activity within the unit and highlighting areas of concern.o Support set up and maintenance of trial master files, site master files and investigator site fileso Assist with the preparation of audits and monitoring visitso Assist with set-up and minuting of meetingso Assist with set-up of site initiation documents and visits
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 on this role, please see the attached detailed Job Description and Person Specification
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 design and implement tools and guidance for clinical trial data capture. To regularly report on data entry status to ensure deadlines are met for interim and final analysis. To represent the Data Management team at research meetings. 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. Tissue tracking using RMH systems (as applicable) Ensure that scans are uploaded to trial specific electronic portals where required. 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.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification
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 design and implement tools and guidance for clinical trial data capture. To regularly report on data entry status to ensure deadlines are met for interim and final analysis. To represent the Data Management team at research meetings. 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. Tissue tracking using RMH systems (as applicable) Ensure that scans are uploaded to trial specific electronic portals where required. 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.
Person Specification
Education/Qualifications
Essential
- Educated to at least GCSE/A level (or equivalent)
Desirable
- Knowledge of ICH/GCP guidelines
Experience
Essential
- Experience in working with databases
Desirable
- Good understanding of medical terminology
- Previous experience of working in the NHS or equivalent
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
- Good level of spoken and written English
Desirable
- Experience of data entry and data management
Other Requirements
Essential
- Ability to support and train team members
Person Specification
Education/Qualifications
Essential
- Educated to at least GCSE/A level (or equivalent)
Desirable
- Knowledge of ICH/GCP guidelines
Experience
Essential
- Experience in working with databases
Desirable
- Good understanding of medical terminology
- Previous experience of working in the NHS or equivalent
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
- Good level of spoken and written English
Desirable
- Experience of data entry and data management
Other Requirements
Essential
- Ability to support and train team members
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.
