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 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

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.

Certificate of Sponsorship

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).

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.

Certificate of Sponsorship

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).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

16th Floor Tower Wing, Guy's Hospital

Great Maze Pond

London

SE1 9RT

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)