The post holder will assist the BRC in the management of a portfolio of clinical studies and support the clinical trials team.
As part of their overall job duties, the successful applicant will work with the BRC's Clinical Trials team to: enable Chief or Principal Investigators to complete submissions for regulatory approval for BRC studies and that the studies run in accordance with all applicable regulatory requirements.
The post holder will also be responsible for the production of study promotional/administrative material, answering of queries and resolving any technical or administrative barriers to participation.
Other key responsibilities will include supporting the BRC Manager with BRC operational projects and processes to ensure the sustainability and growth of the BRCMain duties of the job
Coordinate multiple, large and small scale projects.
Keep up-to-date with the national clinical research environment to remain at the forefront of changes to legislation.
Participate in and facilitate teleconferences and face-to-face meetings as appropriate to discuss trial progress with the Investigators/Collaborators/CTMs/Trial Steering Committees and Data Safety Monitoring Committees.
Present trial information to clinicians, nurses and other healthcare professionals, at site visits and collaborator meetings, as required.
Advise centres on trial related matters including data queries, supplies management and essential documentation.
Contribute to the ongoing development of the NIHR BRC working toward delivery of BRC objectives.
Contribute to the NIHR annual BRC activity report providing quarterly metric updates to the Executive and Operational groups This vacancy is advertised on a fixed term contract basis for a period of 49 months due to the post being externally funded. The fixed term contract status of the post holder will be reviewed in accordance with the Trust's legal obligations regarding fixed term contracts taking into consideration the ongoing source of the external funding and the requirement for the post to be maintained Please also note any secondment must first be agreed with your current line manager.About us
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.Job descriptionJob responsibilitiesPlease view the attached Job Description and Person Specification documents for full details regarding this post. When completing your application please ensure that you clearly demonstrate how you meet the role criteriaPerson SpecificationQualificationsEssential
- Educated to degree level in Health/ Biomedical Sciences/ Neuroscience related subject or equivalent experience in a clinical research environment.
- Project Management qualification or demonstrable equivalent experience.
- Current GCP accreditation
- MSc in Health related/ Biomedical Science/ Neuroscience related subject
Skills and KnowledgeEssential
- Extensive experience of clinical research in the NHS, Academic or commercial environment
- Experience of project design, management and evaluation.
- Experience of the submission and approval process for set up of clinical trials.
- Extensive experience managing clinical research performance metrics.
- Experience of co-ordinating multiple projects at any one time.
- Experience of working independently and as part of a team.
- Experience of working collaboratively with internal and external partners.
- Experience of working in a fast paced, adaptable environment.
- Experience of process innovation and other service improvement initiatives.
- Experience of developing Standard Operating Procedures, Policies and Procedures.
- Knowledge of research processes and research methods applicable to health setting
- Knowledge of Department of Health& Social Care/NIHR research strategy
- Knowledge of research legislation including research governance, ICH GCP, Medicines for Human use (Clinical Trials) Regulations, Data Protection, Human Tissue Act, Mental Capacity Act.
- Knowledge of the national research agenda for NIHR Biomedical Research Centres
- Knowledge of patient and public involvement initiatives.
- Knowledge, experience and maintenance of quality assurance systems.
- Ability to maintain timely, highly complex and accurate information sources and databases.
- Excellent organisational skills and an ability to prioritise an unpredictable workload with frequent disruption
- Understanding and commitment to the need for confidentiality.
- Knowledge of research funding sources, especially NIHR.
Values and behavioursEssential
- Ability to manage a diverse workload and to meet set deadlines on own initiative and without close supervision.
- Ability to work independently, without supervision and to self-motivate.
- Ability to produce high quality performance reports for various stakeholders.
- Ability to analyse and communicate to the BRC Operational Group and Executive Committee complex data from various sources to enable continuous quality and delivery efficiencies.
- Demonstrable self-awareness, an understanding of impact on others and an ability to manage self and maintain professional conduct in difficult and challenging situations.
- Extensive experience of PC applications such as Excel, Word, PowerPoint, Microsoft Project Manager and Access, using skills at an advanced level of expertise.
- Excellent attention to detail, whilst maintaining the ability to see the bigger picture.
- Evidence of report writing and presentation skills
- Proactive in fulfilling needs of researchers.
Employer detailsEmployer name
- Understanding of and ability to demonstrate the Trust PROUD values
Sheffield Teaching Hospitals NHS Foundation TrustAddress
Royal Hallamshire Hospital, NIHR Biomedical Research Centre
Any attachments will be accessible after you click to apply.