Clinical Research Auditor

Health Jobs UK; London; On-site; GBP 30,000 - 50,000

Job description

Detailed job description and main responsibilities

1. Research Audit Management
   1. Maintain an in-depth understanding of good research governance practices and ICH-GCP
   2. Plan, conduct and report routine and directed clinical research compliance audits in accordance with SOPs
   3. Follow-up on corrective actions until resolution
   4. Identify and communicate compliance risks to JRES management
   5. Contribute to reports for the Research Governance Committee
   6. Support organisational research regulatory authority inspections
   7. Contribute to process improvement initiatives
   8. Contribute to the development of local SOPs/documents/templates
   9. Provide training to researchers on amendments and other research procedures as appropriate
2. Amendments Management
   1. Be the primary point of contact for amendments for research studies hosted by St George's
   2. Receive and review amendments for hosted studies via the shared email inbox
   3. Liaise with local research teams and relevant support departments on amendment suitability
   4. Liaise with finance and senior management on any costings/budget implications
   5. Liaise with Principal Investigators, sponsors and Clinical Research Organisations (CROs) in a diplomatic and professional manner
   6. Approve amendments on behalf of the JRES
   7. Record and track amendment approval timelines through the JRES R&D management system, EDGE
   8. Update and disseminate relevant information and documents to research teams and on EDGE
   9. Facilitate these processes in a timely manner to enable St George's to meet required objectives and timelines for the delivery of clinical research
3. Other
   1. Maintain an in-depth understanding of new developments in NHS R&D management and governance
   2. Provide advice and guidance to investigators and other research staff
   3. Support other work of the Research Governance and Delivery team as required, such as providing cover during peak periods and annual leave
   4. Attend and contribute to governance-related committees or meetings as requested
   5. Contribute to the programme of research governance training for research staff and for those new to research, and maintain up-to-date training materials
   6. Contribute to the maintenance and development of the EDGE database
   7. Generate reports to inform Trust and University senior management of ongoing research activity
   8. Contribute information relating to clinical trials governance and delivery to the internet/intranet, news; announcements and general communications
   9. Support the dissemination of information to researchers on relevant clinical research legislation and guidance
   10. Maintain effective document and data management systems, both electronic and manual, to meet both institutions' statutory requirements
   11. Provide feedback internally and to senior management on the outcome of study audits and findings
4. Professional Responsibilities
   1. To have responsibility for the Health, Safety and Welfare of self and others and to comply at all times with the requirement of the Health and Safety Regulations
   2. To ensure confidentiality at all times, only releasing confidential information obtained during the course of employment to those acting in an official capacity in accordance with the provisions of the Data Protection Act and its amendments
   3. To work in accordance with the Trust's Equality and Diversity policy to eliminate unlawful discrimination in relation to employment and service delivery
   4. To promote at all times equal opportunities for staff and patients in accordance with the Trust's policies to ensure that no person receives less favourable treatment than another on the grounds of age; disability; marriage and civil partnership; pregnancy and maternity; race (ethnicity); religion or belief; sex (gender); gender reassignment or sexual orientation.
   5. To maintain and update skills and knowledge as relevant to the role and to maintain Continuous Professional Development
   6. To follow all relevant Trust policies and professional codes and to maintain registration where this is a requirement of the role
   7. To be trained in and demonstrate fair employment practices, in line with Trust policies
   8. To undertake such duties as may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service.

Person specification

Education and Training

Essential criteria

• Educated to degree level or equivalent experience

Desirable criteria

• Degree in a bioscience or medical subject

Previous Experience and Knowledge

Essential criteria

• Research administration or coordination experience in an NHS R&D, pharmaceutical or academic research environment

Desirable criteria

• Experience of UK and NHS research approval processes
• Working knowledge of legislation and guidelines relevant to clinical research

Skills

Essential criteria

• Excellent written and verbal communication skills, including report writing skills
• Ability to communicate complex information to multiple stakeholders in an effective and professional manner
• Analytical skills
• Ability to effectively organise own workload with minimum supervision and to work within tight deadlines

Desirable criteria

• Familiarity with the EDGE database
• An understanding of issues surrounding research compliance and reporting
• Experience of writing and working to Standard Operating Procedures

Other Qualities

Essential criteria

• Excellent attention to detail

We expect all our staff to share the values that are important to the trust - being excellent, kind, responsible and respectful - and behave in a way that reflects these. More information on the vision and values of St. George's University Hospitals NHS Foundation Trust is attached below.

Please note that this vacancy may close before the advertised closing date if sufficient applicants are received. Please check your email regularly as all candidates shortlisted for interview will be contacted and informed by email.

If you are appointed to the post, as part of your pre-employment check we will be required to verify your identity. The document/s you present for this purpose will be checked for their authenticity by scanning all known security features. These features will include:

• The machine readable zone
• An ultra violet image
• An infra red image

As part of your pre-employment checks, we will also be required to obtain satisfactory, written references. Please ensure that the referee details which you provide on your application form are correct. We require at least one written reference from your current or most recent line manager. We are only able to accept references from a professional work email address.

Disability Advice Line: S WL Recruitment Hub is committed to promoting equity and equal opportunities for individuals with disabilities. We believe that greater diversity and inclusion will lead to an even more positive impact on the people we serve. For support with job opportunities and reasonable adjustments contact our Confidential Disability Advice Line at:

Telephone: [phone]

Text: 07501066267

Email: [email protected]

Our confidential answering service is available after 5pm.

Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Clinical Research Auditor ( PDF , 145.5 KB )
• Referee Contact details form ( PDF , 200.6 KB )