Job summary
Are you looking to develop your career in clinical trial management? Would you like to join a dynamic and motivated team delivering cutting-edge translational research?
We are looking for a part-time (0.6 FTE) assistant clinical trial manager to join our Clinical Trial Management Team based at Guy's & St. Thomas' NHS Foundation Trust.
Previous experience of working on clinical trials, either in the NHS, industry or academic setting is essential.
Main duties of the job
As part of the team supporting researchers within Kings Health Partners, you will play a key role in the set up and delivery of innovative clinical studies, testing advanced cellular, biological and drug therapies across a range of therapeutics areas.
About us
You will be passionate about the research we support, motivated to deliver high quality research and committed to working in a dynamic multi-disciplinary environment.
This is a part-time (0.6 FTE), predominately office based role at Guy's Hospital, with occasional travel to participating centres within the UK. Hybrid working is supported, and the current pattern for a part time post is twodays in office/ one day working remotely. Please note, we can not answer any queries about this working pattern while the position is advertised.
In return we offer training and development to progress your career in clinical trial management. This is a great opportunity to gain experience of clinical research from the Sponsor perspective and grow within a well-structured and supportive environment.
Job description
Job responsibilities
You will work alongside Clinical Trial Managers and Data Managers to support our trials. You will develop strong working relationships with investigators and clinical staff to ensure the research is conducted to the highest standards, in line with all applicable regulatory requirements. This wide-ranging role will include completing submissions to regulatory authorities, developing clinical trial protocols and patient facing documentation, and acting a a key contact for any study queries.
Job description
Job responsibilities
You will work alongside Clinical Trial Managers and Data Managers to support our trials. You will develop strong working relationships with investigators and clinical staff to ensure the research is conducted to the highest standards, in line with all applicable regulatory requirements. This wide-ranging role will include completing submissions to regulatory authorities, developing clinical trial protocols and patient facing documentation, and acting a a key contact for any study queries.
Person Specification
Qualifications
Essential
- Science degree in an appropriate field, or equivalent experience.
Desirable
- Post graduate qualification or equivalent in Clinical Research
Experience
Essential
- Understanding of current issues in delivery of clinical trials research.
- Competent in using Microsoft Office software and creating spreadsheets
Desirable
- Experience of working on CTIMP multi-centre studies
- Experience of writing study documents and completing IRAS/REC submissions
Knowledge / Skills
Essential
- Knowledge of the EU Clinical Trials Directive, The Medicines for Human Use (Clinical Trials) Regulations, ICH GCP, Research Governance legislation, and how they apply when managing a clinical trial
- Understanding of clinical research methodology.
- Awareness of Data Protection Regulations and how they apply to clinical trials
- Evidence of effective communication, presentation and inter-personal skills with professionals at all levels.
- Proven ability to work independently and as part of a team.
- Proven ability to organise and prioritise workload to meet competing deadlines
Person Specification
Qualifications
Essential
- Science degree in an appropriate field, or equivalent experience.
Desirable
- Post graduate qualification or equivalent in Clinical Research
Experience
Essential
- Understanding of current issues in delivery of clinical trials research.
- Competent in using Microsoft Office software and creating spreadsheets
Desirable
- Experience of working on CTIMP multi-centre studies
- Experience of writing study documents and completing IRAS/REC submissions
Knowledge / Skills
Essential
- Knowledge of the EU Clinical Trials Directive, The Medicines for Human Use (Clinical Trials) Regulations, ICH GCP, Research Governance legislation, and how they apply when managing a clinical trial
- Understanding of clinical research methodology.
- Awareness of Data Protection Regulations and how they apply to clinical trials
- Evidence of effective communication, presentation and inter-personal skills with professionals at all levels.
- Proven ability to work independently and as part of a team.
- Proven ability to organise and prioritise workload to meet competing deadlines
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
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).
