Clinical Trials Monitor
3 weeks ago
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**:
The post holder 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 organization and its partners and collaborators in NHS Trusts, Charities, Research Councils, 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:
- To be responsible for the monitoring, conduct, progress review and documentation of the organization’s sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV).
- Review trial protocols using risk assessment tools and compile individual monitoring plans commensurate with the scale of the trial. To provide written reports on monitoring findings and progress to the trial Chief Investigators, research teams and the RGIT Clinical Trial Manager and to escalate any key findings appropriately.
- To ensure that all appropriate medication manufacture, supply and release documentation is in place before the trial commences. To ensure each trial has a system for documenting IMP drug accountability and traceability.
- To ensure all trial related Standard Operational Procedures (SOP’s) are adhered to and in particular the recording, reporting and tracking of Serious Adverse Events, Adverse Reactions and annual/ end of trial reporting.
- To coordinate trial initiation visits within the RGIT before any research activity commences, to include review of facilities where trial activity is taking place and obtaining a signed Investigator agreement highlighting research responsibilities.
You will have a role in developing and supporting the research governance systems required throughout the organization.
**Essential requirements**:
**Further information**:
This position is full-time and open-ended.
- 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._
**Documents**:
- Job-Description - Clinical Trials Monitor - Final.pdf
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