Clinical Trials Monitor

Job summary

We have an exciting opportunity for a Clinical Trial Monitor to join Imperial College London’s Research Governance and Integrity Team (RGIT). You will be based at St Mary’s Hospital, London with travel to other Trust and College sites. 

You will report directly to the RGIT Clinical Trial Manager, and work with her/him to provide administrative and operational support, in partnership with other members of the RGIT, to ensure that all IMP Clinical Trials are managed in line with the sponsorship requirements and regulation. 

Duties and responsibilities

He/she will be the first point of contact for researchers requiring trial monitoring support in the organization.  He/she will also act as a liaison between the Sponsor’s organisation and its partners and collaborators in NHS Trusts, pharmaceutical and other industrial companies to facilitate the set-up and co-ordination of the monitoring provisions for the portfolio of sponsored clinical trials.

Key responsibilities will include:

• Reviewing sponsor and site trial documents and performing source document verification (SDV).
• Compiling individual monitoring plans commensurate with the scale of the trial.
• Providing monitoring reports to the trial Chief Investigators, research teams and the RGIT Clinical Trial Manager and to escalate any key findings appropriately.
• Ensuring that appropriate medication manufacture, supply and release documentation is in place before the trial commences. Including drug accountability and traceability.
• Ensuring Standard Operational Procedures (SOP’s) are adhered to.
• Oversight of the recording, reporting and tracking of Serious Adverse Events/Reactions, annual and end of trial reporting.
• Coordinating trial initiation visits before any research activity commences, to include review of facilities where trial activity is taking place.  

Essential requirements

 Those wishing to apply will have a degree in the area of health care, biological science or a related discipline and will have experience of clinical trials in an NHS Trust and/or Higher Education Institute (HEI) environment, an in-depth understanding of clinical research regulations, research governance and the principles of GCP. Candidates must have excellent interpersonal skills, attention to detail and be highly organised. This role requires the post holder to work on their own initiative and have the ability to manage several projects at once.

The role is in a dedicated team, within a challenging and rewarding environment so candidates must have good time-management skills and demonstrate a strong team-work ethic. Applicants should be committed to continuous professional development in research monitoring to ensure that the RGIT are delivering an excellent service to the researchers of the University and NHS Trust.

Further information

Candidates will be required to complete an online application via the Imperial College London website.

Should you require any further details on the role please contact: Rinat  Ezra –  r.ezra@imperial.ac.uk

The College is currently trialling a Work Location Framework until early 2023.  Hybrid working may be considered for this role and the role holder may be expected to work 60% or more of their time onsite, with 40% the minimum time spent onsite.  The opportunity for hybrid working will be discussed at interview.

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