Job summary
An exciting opportunity has arisen for an amendments officer with clinical trial assistant duties to work as part of the Cancer Research Delivery Group (CRDG) at the Barts Centre for Experimental Cancer Medicine (CECM).
The post-holder will work within the multi-disciplinary team as an amendments officer with Clinical Trial Assistant (CTA) duties. It is anticipated that there will be a roughly 50:50 split although this may be adjusted according to the workloads.
Main duties of the job
o Assist the Amendments Officer with the co-ordination and implementation of Cancer amendments:o Manage and process cancer study amendments in line with country regulations and internal SOPso Maintain tracking of process through Excel based trackers and other database systems (EDGE)o Work closely with supporting departmentso Communicate with Sponsor and internal teamso Accurately collect and record essential trial information being mutually supportive and covering duties as necessary during colleagues' absences and at times of additional pressure.o Collection of clinical data on Case Report Formso Maintenance of a database of trial activityo Maintaining site files and processing amendmentso Ensuring that the trials are run according to current national law; local guidelines and procedures; following the principles of Good Clinical Practice (GCP)
About us
Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers.
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.
We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment.
Job description
Job responsibilities
We are seeking an enthusiastic individual with high levels of attention to detail and is energised by working in a challenging and fast paced environment. The candidate will work within a highly effective team and should have good IT and communication skills. Experience of clinical trials is essential.
The successful candidate will have previous experience in an administrative background ideally within an NHS or research setting. You must provide demonstrable IT skills, including: e-mail, word processing and databases, along with attention to detail and high standards of accuracy with the ability to follow instructions. Previous experience of clinical data entry and familiarity with Good Clinical Practice (GCP) and the regulatory environment that surrounds clinical research would be an advantage.We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Job description
Job responsibilities
We are seeking an enthusiastic individual with high levels of attention to detail and is energised by working in a challenging and fast paced environment. The candidate will work within a highly effective team and should have good IT and communication skills. Experience of clinical trials is essential.
The successful candidate will have previous experience in an administrative background ideally within an NHS or research setting. You must provide demonstrable IT skills, including: e-mail, word processing and databases, along with attention to detail and high standards of accuracy with the ability to follow instructions. Previous experience of clinical data entry and familiarity with Good Clinical Practice (GCP) and the regulatory environment that surrounds clinical research would be an advantage.We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Person Specification
Experience
Essential
- Previous experience of clinical trial data entry
- Previous experience in an administrative background (ideally within an NHS or research setting)
- Experience of working as part of a multidisciplinary team
Desirable
- Knowledge of ICH/GCP, MHRA guidelines for amendments and HRA/REC processes
- Familiarity with Good Clinical Practice and the regulatory environment that surrounds clinical research
Qualifications
Essential
- A-Levels in biological sciences
Desirable
Knowledge
Essential
- Good knowledge of administration / IT systems (Excel)
Desirable
- Good knowledge of local and national clinical trial regulations
- Proven knowledge of ICH GCP guidelines
- Knowledge and understanding or medical terminology
Skills
Essential
- Demonstrable IT skills, including: e-mail, word processing and databases (Microsoft Office packages, other database programmes)
- Must demonstrate attention to detail and high standards of accuracy and an ability to follow instructions
- Demonstrates ability to prioritise workload in order to meet deadlines/milestones
- Proven ability to work effectively under pressure
- Demonstrates organizational skills (filing, tracking, process)
- Proven ability to work within SOPs / Regulations
- Effective communication in written and verbal English
- Demonstrates a commitment to further learning and professional development
Desirable
- Previous use of Trials Research Management Software e.g. EDGE
Other
Essential
- Friendly, enthusiastic, positive and professional disposition
- Ability to work on own initiative and problem solve to organise and manage the work of a professional team under management guidance
- Flexible and co-operative
- Willingness to work on different Barts NHS Trust sites
Person Specification
Experience
Essential
- Previous experience of clinical trial data entry
- Previous experience in an administrative background (ideally within an NHS or research setting)
- Experience of working as part of a multidisciplinary team
Desirable
- Knowledge of ICH/GCP, MHRA guidelines for amendments and HRA/REC processes
- Familiarity with Good Clinical Practice and the regulatory environment that surrounds clinical research
Qualifications
Essential
- A-Levels in biological sciences
Desirable
Knowledge
Essential
- Good knowledge of administration / IT systems (Excel)
Desirable
- Good knowledge of local and national clinical trial regulations
- Proven knowledge of ICH GCP guidelines
- Knowledge and understanding or medical terminology
Skills
Essential
- Demonstrable IT skills, including: e-mail, word processing and databases (Microsoft Office packages, other database programmes)
- Must demonstrate attention to detail and high standards of accuracy and an ability to follow instructions
- Demonstrates ability to prioritise workload in order to meet deadlines/milestones
- Proven ability to work effectively under pressure
- Demonstrates organizational skills (filing, tracking, process)
- Proven ability to work within SOPs / Regulations
- Effective communication in written and verbal English
- Demonstrates a commitment to further learning and professional development
Desirable
- Previous use of Trials Research Management Software e.g. EDGE
Other
Essential
- Friendly, enthusiastic, positive and professional disposition
- Ability to work on own initiative and problem solve to organise and manage the work of a professional team under management guidance
- Flexible and co-operative
- Willingness to work on different Barts NHS Trust sites
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).
