Detailed job description
The post holder will be responsible for initiating discussions with clinical and academic colleagues regarding possible research opportunities, applications and collaborations. They will build effective working relationships with current and prospective Chief Investigators and other research stakeholders to ensure appropriate support is in place to conduct trust sponsored research safely, efficiently and effectively.
They will act as the named facilitator and / or project manager for allocated studies, supporting the chief investigator to develop their study idea and apply for Sponsorship approval, taking primary responsibility for ensuring effective oversight of study conduct on behalf of the Sponsor.
The post holder will manage their own workload whilst providing comprehensive, high quality, efficient and effective support to the Research and Development department.
and main responsibilities
Person specification
Qualifications
Essential criteria
- Educated to degree level in life sciences or able to demonstrate equivalent level of knowledge, skills and understanding in Research & Development (R&D)
- Recent certificate of International Conference on Harmonisation Good Clinical Practice (ICH GCP) training
- A willingness to undergo personal development and training and learn new skills.
Desirable criteria
- Master’s degree or willingness to undertake
- Attended relevant training in research methodology / delivery / management
Experience
Essential criteria
- Significant (at least three years) experience of working in a clinical trials research team within an NHS hospital or university setting, conducting and organising studies
- Experience of using the Integrated Research Application System (IRAS)
- Detailed and up-to-date knowledge of Health Research Authority (HRA) legislative and regulatory bodies’ requirements
- Experience of research facilitation, governance and management
- Significant experience of working to tight deadlines and managing a range of priorities
- Experience of writing concise reports and presenting complex information
- Experience in supporting the collection, management and analysis of research data
Desirable criteria
- Experience working within a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit
- Experience with facilitating and / or preparing applications for research grant funding
- Experience of budget management
- Experienced in the facilitation of site monitoring visits
Skills
Essential criteria
- High standards of literacy, numeracy and attention to detail
- IT literate - advanced knowledge of Microsoft applications e.g. Word, Excel, PowerPoint, Outlook
- Advanced understanding of working with a variety of web-based platforms (e.g. NIHR CPMS, EDGE, IRAS)
- Ability to analyse, interpret and communicate complex information in a concise manner
Desirable criteria
- Basic working knowledge of statistical methods and / or experience with SPSS software package
Knowledge
Essential criteria
- Understanding of medical terminology
- Sound understanding of clinical research terminology and methodology
- Ability to demonstrate an understanding of study specific protocol requirements and implement strategies to facilitate protocol adherence and successful study delivery
- Working knowledge of the UK clinical trials regulations, Information Governance and Data Protection Act (2018), Mental Capacity Act, Human Tissue Act, ICH-GCP), Research Governance and ethical Frameworks
Personal Attributes
Essential criteria
- Excellent written and oral communication skills
- Able to work under own initiative and independently outside of the department without direct supervision
- Ability to prioritise tasks and manage time effectively, coping with deadlines