Guy's and St Thomas' NHS Foundation Trust

Trial Manager / Clinical Research Practitioner II

The closing date is 29 June 2025

Job summary

We are seeking a dynamic and experienced Clinical Research Practitioner to manage the LISA study, a clinical trial investigating treatments for bacterial vaginosis and candida. This exciting study compares standard oral treatments to vaginal lactoferrin and includes both quantitative and qualitative components. The successful candidate will lead on all trial management activities including recruitment, data quality, participant follow-up, and sample handling, ensuring adherence to ICH-GCP standards.

This is a part-time position based across two main research sites: Burrell St Sexual Health Clinic and Curran General Practice in Clapham.

Main duties of the job

  • Manage day-to-day operations of the LISA trial including recruitment, randomisation, consent, and follow-up of study participants.

  • Conduct qualitative interviews with participants to support the study's mixed-methods design.

  • Organise and lead Trial Management Group and Trial Steering Group meetings, presenting progress and recruitment updates.

  • Liaise with Clinical Trials Unit to manage study database and randomisation system.

  • Coordinate collaboration with internal departments (e.g., R&D, Pharmacy, Labs) and external bodies (e.g., IMP manufacturers).

  • Develop and maintain trial-specific documentation, SOPs, and the Trial Master File (TMF).

  • Organise and ensure quality control of participant sample packs and sample tracking, analysis, and storage.

  • Support protocol amendment processes and represent the trial at conferences and stakeholder meetings.

About us

You will be joining one of the UK's most respected NHS Trusts, committed to delivering cutting-edge research that directly informs and enhances patient care. The Trust is a major centre for academic and clinical excellence and provides an inclusive, supportive environment for career development and research delivery.

Details

Date posted

11 June 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£44,806 to £53,134 a year per annum inc HCA

Contract

Fixed term

Duration

12 months

Working pattern

Part-time

Reference number

196-RD315

Job locations

Burrell St Sexual Health Clinic

Burrell St

London

SE1 0UN


Job description

Job responsibilities

Clinical and Communication Responsibilities

  • Manage a caseload of participants, ensuring informed consent and compliance with trial protocols.

  • Perform clinical assessments (e.g., vitals, sample collection, urinalysis) and support biological sample preparation.

  • Report adverse events and deviations from protocol in a timely and professional manner.

  • Maintain accurate and complete participant records and liaise effectively with the clinical team.

Research and Portfolio Management
  • Assist in study setup, protocol reviews, and R&D submissions.

  • Maintain accurate CRFs and ensure timely resolution of data queries.

  • Monitor and report recruitment metrics, support study accrual efforts, and liaise with sponsors.

  • Ensure all trial documentation is archived and compliant with regulatory requirements.

Management and Leadership
  • Line manage junior research staff as required and contribute to performance appraisals.

  • Lead on policy implementation and service quality improvements.

  • Act as a role model and mentor within the research team and represent the Trust in external forums.

Education & Professional Development
  • Maintain professional development through ongoing training and reflective practice.

  • Contribute to SOP development and support educational activities across the research department.

Additional Responsibilities
  • Ensure responsible use of research equipment and resources in line with study budgets.

  • Work flexibly to meet the needs of the study, including occasional evenings or weekends.

  • Foster cross-departmental collaboration and integration of research within clinical services.

Job description

Job responsibilities

Clinical and Communication Responsibilities

  • Manage a caseload of participants, ensuring informed consent and compliance with trial protocols.

  • Perform clinical assessments (e.g., vitals, sample collection, urinalysis) and support biological sample preparation.

  • Report adverse events and deviations from protocol in a timely and professional manner.

  • Maintain accurate and complete participant records and liaise effectively with the clinical team.

Research and Portfolio Management
  • Assist in study setup, protocol reviews, and R&D submissions.

  • Maintain accurate CRFs and ensure timely resolution of data queries.

  • Monitor and report recruitment metrics, support study accrual efforts, and liaise with sponsors.

  • Ensure all trial documentation is archived and compliant with regulatory requirements.

Management and Leadership
  • Line manage junior research staff as required and contribute to performance appraisals.

  • Lead on policy implementation and service quality improvements.

  • Act as a role model and mentor within the research team and represent the Trust in external forums.

Education & Professional Development
  • Maintain professional development through ongoing training and reflective practice.

  • Contribute to SOP development and support educational activities across the research department.

Additional Responsibilities
  • Ensure responsible use of research equipment and resources in line with study budgets.

  • Work flexibly to meet the needs of the study, including occasional evenings or weekends.

  • Foster cross-departmental collaboration and integration of research within clinical services.

Person Specification

Qualifications/ Education

Essential

  • Degree in life sciences or related field or equivalent theoretical knowledge
  • Evidence of continuing professional development
  • GCP certificate

Desirable

  • Registered on AHCS clinical research practitioner accredited register

Previous experience

Essential

  • Significant experience in relevant clinical research delivery setting
  • Experience managing complex projects

Desirable

  • Experience within speciality

Skills/Knowledge/ Ability

Essential

  • Excellent communication skills and ability to deal with complex and sensitive situations
  • Ability to work autonomously and as a member of a small team, as well as part of the wider multidisciplinary team

Desirable

  • Proficient with basic laboratory skills

Physical Requirements

Essential

  • Willingness and ability to travel to external meetings within the context of this post
  • Able to concentrate for prolonged periods when cross-referencing medical case notes
Person Specification

Qualifications/ Education

Essential

  • Degree in life sciences or related field or equivalent theoretical knowledge
  • Evidence of continuing professional development
  • GCP certificate

Desirable

  • Registered on AHCS clinical research practitioner accredited register

Previous experience

Essential

  • Significant experience in relevant clinical research delivery setting
  • Experience managing complex projects

Desirable

  • Experience within speciality

Skills/Knowledge/ Ability

Essential

  • Excellent communication skills and ability to deal with complex and sensitive situations
  • Ability to work autonomously and as a member of a small team, as well as part of the wider multidisciplinary team

Desirable

  • Proficient with basic laboratory skills

Physical Requirements

Essential

  • Willingness and ability to travel to external meetings within the context of this post
  • Able to concentrate for prolonged periods when cross-referencing medical case notes

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).

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.

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

Burrell St Sexual Health Clinic

Burrell St

London

SE1 0UN


Employer's website

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


Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Burrell St Sexual Health Clinic

Burrell St

London

SE1 0UN


Employer's website

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


Employer contact details

For questions about the job, contact:

Research Manager

Amy Day

amy.day@gstt.nhs.uk

Details

Date posted

11 June 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£44,806 to £53,134 a year per annum inc HCA

Contract

Fixed term

Duration

12 months

Working pattern

Part-time

Reference number

196-RD315

Job locations

Burrell St Sexual Health Clinic

Burrell St

London

SE1 0UN


Supporting documents

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