Clinical Trials Agreements Associate
The Clinical Trials Office is a department which exists to serve the research agenda of King’s Health Partners by providing a single interface for those wishing to conduct clinical trials within the Partner Organisations. If you have a background in research within Higher Education, currently work in NHS R&D or Clinical Trials Administration in the Pharmaceutical or Allied Health Care and would like to work in a dedicated team with opportunity for career progression, we would like to hear from you.
The role is part of a busy team of Clinical Trials Agreements Associates providing an efficient and effective contractual service for investigators, companies and contract research organisations that are seeking to conduct commercial clinical trials within the Partner Organisations. Members of the team work closely with our research teams and clients to cost projects and negotiate contracts. Candidates will ideally have experience in costing and negotiating project budgets, as well as standard contracts in the Academic or NHS sector, or in the pharmaceutical and allied health industries. An understanding of the legal, regulatory and statutory governance of clinical trials, or other regulated environments, will be an advantage.
Most importantly, we seek candidates who are able to think analytically, are confident and persuasive communicators with excellent written English, and who can successfully manage a diverse and very busy workload largely autonomously.
This post will be offered on an indefinite contract
This is a full-time post - 100% full time equivalent
• Responsible for providing an effective, high quality, timely and efficient contractual and financial/budgetary service to investigators, companies and contract research organisations seeking to conduct commercial trials in any of the Partner Organisations.
• To review and negotiate contractual conditions in accordance with KHP-CTO policy and national guidance, referring to the Senior CTAA as appropriate.
• To calculate and negotiate clinical trial budgets in accordance with CTO policy and NIHR guidance, ensuring that the revenue to the Partner Organisations from participating in commercial studies is maximised.
• To ensure that the set-up and administration of Commerical trials is in compliance with the relevant legal, regulatory and internal governance.
• To give appropriate advice regarding the contractual and financial terms of contracts to stakeholders.
• To work closely with academic, clinical and other staff, at all levels and across the Partner Organisations, to develop effective working relationships and to grow clinical trial activity.
• To communicate the progress of projects and provide metrics in appropriate formats to the Senior CTAA.
• To keep abreast of all current relevant KHP-CTO policy and NIHR guidance and assist the Senior CTAA in ensuring that all stakeholders are kept abreast of changes in policy or process affecting the contractual and financial elements of clinical trial activity.
• To actively contribute to the Agreements team and the wider KHP-CTO, working flexibly as a member of both teams.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. Possess relevant experience.
2. Proficient negotiator with ability to influence and strong interpersonal skills.
3. The ability to build successful relationships, collaborate in cross-functional teams and maintain a positive work environment.
4. Knowledge, understanding and experience of the regulatory and statutory governance of clinical trials.
5. The ability to manage a large and diverse portfolio of contracts.
6. The ability to work to SOPs and local working processes.
7. Excellent organisational and time management skills.
8. Excellent written and verbal communication skills.
9. Demonstrably high levels of accuracy and attention to detail.
10. Practical problem-solving skills and the ability to think analytically.
11. Self-starting and able to work largely unsupervised.
12. Strong computer skills (proficient with MS word, Excel and web-based applications).
1. Experience of commercial clinical trial set up.
2. Knowledge and understanding of the relevant contract templates.
3. Knowledge of the regulatory requirements for clinical trials and GCP.
4. Knowledge of medical, scientific and/or research terminology.
5. Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS.
6. Direct, relevant work experience in field of clinical trials and sponsored research.
The Kings Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It has been set up to provide a single interface for those wishing to conduct clinical trials within the Partner Organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk