St George's University Hospitals NHS Foundation Trust
Information:
This job is now closed
Job summary
St George's Joint Research and Enterprise Services (JRES) is currently looking for an enthusiastic, proactive, flexible and pragmatic individual to work within the Research Governance and Delivery team as a Clinical Research Auditor.
The role will act to ensure certain studies are audited to meet national research governance legislation and best practice. The individual will also ensure post-approval amendments for hosted projects are received, reviewed and approved within designated timelines, liaising closely with research teams, finance, support departments and external research sponsors. The post holder will be required to have excellent attention to detail, good organisational skills and be able to maintain good working relationships and a high level of customer service with all stakeholders.
Previous experience within clinical research, ideally within a hospital and/or HEI setting, with familiarity with medical terminology, would be advantageous.
Main duties of the job
1. Conducting sponsor audits for studies hosted or sponsored by St George's
2. Managing and processing post-approval study amendments for hosted studies
Job 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 Georges
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 Georges 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 Trusts 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 Trusts 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
* Educated to degree level or equivalent experience
* Degree in a bioscience or medical subject
Previous Experience and Knowledge
* Research administration or coordination experience in an NHS R&D, pharmaceutical or academic research environment
* Experience of UK and NHS research approval processes
* Working knowledge of legislation and guidelines relevant to clinical research
Skills
* 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
* 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
* Excellent attention to detail
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.
Employer name
St George's University Hospitals NHS Foundation Trust
Research Development and Governance Manager
£35,964 to £43,780 a year p.a. pro rata inclusive of HCAS (Inner)
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