Information for Applicants
The UKCRC Registered Clinical Trials Unit (CTU) Network is seeking a highly experienced person with expertise in clinical trials to contribute IS and Data Management expertise to its International Registration Review Committee.
The successful candidate will have a wealth of experience, knowledge, and acumen within the field of non-commercial/academic clinical trials research, demonstrate an excellent understanding of best practice as well as current drivers for change.
Given the nature of the role, the IS and Data Management expert member should not be currently directly associated with one or more CTUs in the UK and must therefore have an Emeritus or non-CTU based position within the UK or internationally.
The CTU Network brings together fifty-one non-commercial units from across the UK.
As the collective voice of non-commercial and academic clinical trials units, the Network plays an important role in engaging with Government, funders, regulators, and patients to improve and strengthen clinical research in the UK. The Network is seen internationally as an exemplar for the development of national clinical trials support. It was established in 2007 and its members are committed to setting and sharing good practice and improving standards in clinical trials.
The UKCRC CTU Network is funded by its members, and major funders have representation on the Network’s Executive Group, this includes: Cancer Research UK, NIHR, Versus Arthritis, Chief Scientist Office Scotland and Health and Social Care Research Wales.
This role does not involve any report writing, all administration for the biannual meetings is supported by the Network’s Secretariat.
Role description
Responsibilities:
- Provide input into the design of the Registration criteria relating to their specialist area to ensure that they remain appropriate and fit for purpose.
- Review applications from new and existing CTUs against the published Registration criteria and provide feedback on their suitability for Registration.
- Provided feedback on queries from the IRRC and/or Network Secretariat in relation to ad hoc correspondence from currently Registered CTUs where that related to their specialist area.
- Maintain awareness of the clinical trials environment and key national and international issues affecting clinical trials units.
- Support the IRRC chair in setting the strategic direction of the registration process and membership.
Key attributes
- Experience in setting up and / or overseeing Quality Management Systems (QMS) for Clinical Trials
- Expertise in writing and reviewing Quality documents including Policies, standard Operating Procedures etc.
- Thorough knowledge of ICH-GCP
- Familiarity with Quality Processes and procedures relevant to the Clinical Research area.
In addition to the key attributes above, candidates should bring skills and experience in the following area:
- Information Technology/Information Systems – a detailed understanding of the use of IT systems within clinical trials inc. validation, data management, and data security.
Personal attributes
- A strong background in clinical trials research either within the UK or internationally
- Integrity, diplomacy, strategic vision, and sound judgement.
- Committed to the values and purpose of the Network.
- An in depth understanding of the strategic opportunities and challenges in UK clinical trials research and the role of CTUs within the environment.
- The ability to think strategically and objectively, take the long view.
- A collaborative working style that reflects the Network’s values with strong relationship-building and communication skills
- Ability to chair meetings well, encouraging debate and facilitating decision-making
- Negotiation and diplomacy skills with the ability to have courageous conversations
Governance and reporting arrangements
The post-holder is responsible to the UKCRC CTU Network Executive Board and the UKCRC Board (Chaired currently by Lucy Chappell). The Chair will have a key relationship with the UKCRC Programme and Delivery Manager and the Chair of the UKCRC CTU Network Executive Board (currently Simon Denegri OBE, Chief Exec, Academy of Medical Sciences).
Terms of Reference for the Committee are available here.
Travel and attendance at meetings
Due to the self funded nature of the Network, travel expenses and hotel accommodation will be reimbursed for face-to-face meetings. Teleconferences will be used where the number of applications makes this feasible.
How to apply
Interested candidates are asked to submit an up-to-date short CV plus covering letter (500 words) outlining their vision for the role and how they believe they fulfil the role description by 6pm on Monday 16 September 2024.
