Sponsor Regulatory Advisor

2 months ago

London, United Kingdom University College London Full time

**Ref Number**

B07-00115

**Professional Expertise**

Research and Research Support

**Department**

VP: Health (B07)

**Location**

London

**Working Pattern**

Full time

**Salary**

£42,099-£50,585

**Contract Type**

Fixed-term

**Working Type**

Hybrid (20% - 80% on site)

**Available For Secondment**

Yes

**Closing Date**

07-Mar-2024

**About us**:
The JRO was established in August 2006. The JRO has a central focus on providing research management and governance support to biomedical research studies across both Institutions and ensures researchers continue to contribute to the high scientific and cutting edge research that currently exists.

The JRO provides research support services to facilitate compliance with regulations for an extensive portfolio of clinical research studies conducted across the organisation(s). A particular focus within the JRO are clinical trials (CTIMPs) and Device Clinical Investigations; with the trials team involved in a variety of trials functions such as sponsorship authorisation, negotiating sponsorship agreements, supporting regulatory authorisations, pharmacovigilance, training researchers, project planning and management to ensure successful conduct of research from concept to trial completion and publication. Supporting these activities is a central database of all biomedical projects and a joint website to ensure adequate and effective dissemination of information.

**About the role**:
An enthusiastic individual is sought for a 2 year fixed term post, which is based at 250 Euston Road, London NW1 2PG

The Sponsor Regulatory Advisor will report to the Clinical Trials Operations Manager and will work alongside existing Sponsor Regulatory Advisors, Compliance Oversight Advisors (Clinical Monitors), and other key members of the Trials Team.

The post holder will be responsible for oversight of the UCL portfolio of trials. This is a key appointment within the Unit and a strong desire to promote a high quality, professional and supportive approach to assist investigators with their trial set up is essential.

The post holder will assist Investigator teams on behalf of UCL as sponsor to ensure the efficient coordination of clinical trials and ensure that trials are set up and run in accordance with current regulatory requirements. An important aspect of this role will be close liaison with the many trial sites both UK and International. Based at Maple House, occasional travel may be necessary to participating sites in the UK.

General trial coordination
- Provide investigators and their research teams with strongly supportive clinical trials advice, acting as a key interface between the Joint Unit and the research teams;
- Review and assist with costing new, high quality clinical trial proposals at UCL and to prepare trials for delivery through the UCLH/UCL Comprehensive Biomedical Centre;
- Facilitate gathering of trial information from research team and advising research teams about sponsorship arrangements and Unit policies and procedures;
- Review of trial related documents and undertaking risk assessment with trials team, in preparation for sponsorship approval;
- Setting up and maintenance of Sponsor’s Files with essential documents and liaising with relevant members of the clinical trials team to ensure all trial related docs are in place prior to commencement of trial;
- Undertaking Regulatory and REC submissions and any amendments necessary;
- Complete Site Initiation, Close out and Archiving procedures;
- Coordinate site documents and maintain version control in collaboration with trial monitors;
- Producing regular trial update reports for the Unit;
- Answer queries from research staff promptly and efficiently in relation to the requirements of legislation impacting on the conduct of clinical trials, acknowledging all communication, and ensuring efficient flow of information
- Interpret policy requirements, write workable operational processes, and work with senior researchers and clinicians to ensure that new procedures are implemented widely.

Site management
- Liaise with participating sites, identifying key staff and updating them on trial processes and ensuring centres are able to comply with study protocol;
- Ensuring all relevant documentation and contracts are in place for each site;
- Coordinate updating sites with necessary trial docs liaising with CI and trial monitors as required;
- Liaise with trial monitors to ensure trial sites are monitored according to monitoring plan for trial;
- Liaise with the Pharmacovigilance (PV) Manager to ensure prompt processing and reporting of serious adverse events according to regulatory guidelines
- Liaise with the Regulatory Manager
- Pharmaceuticals (RMP) to manage any IMP related activities in set up or during CTIMP trials

Audit and Inspections

**About you**:
This role offers the unique opportunity to work closely across the University and the NHS. The Sponsor Regulatory Advisor (SRA) works directly wi

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