Clinical Trials Feasibility Officer
The Clinical Trials Feasibility Officer (CTFO) will provide administrative support to a busy feasibility team providing an efficient and effective feasibility service for investigators, companies and contract research organisations that are engaging in commercial clinical trials within the Partner Institutions.
The CTFO will act as the point of contact for commercial studies submitted through the NIHR Clinical Research Network, being a liaison between South London CRN, KHP Partners (both clinical and administrative) and commercial sponsors of clinical trials to manage expression of interests and feasibility assessments for proposed commercial clinical trials
The CTFO will conduct robust feasibility assessments for commercial clinical studies across a board range of therapeutic areas and develop processes to increase and continuously improve efficiency of the Clinical Trials Office’s feasibility service.
Candidates will ideally hold a degree or an equivalent qualification and have experience in setting up trials in the pharmaceutical and allied health industries and/or the NHS/Academic sector. An understanding of the legal, regulatory, and statutory governance of clinical trials is required.
Most importantly, we seek candidates who can think analytically, are confident and persuasive communicators with excellent written English, and who can successfully manage a diverse and very busy workload largely autonomously.
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 institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.
- To manage the CRN Site Identification process for KHP.
- To provide administrative support to the feasibility team
- To ensure compliance with the relevant legal, regulatory and internal governance.
- To communicate effectively with all stakeholders, giving accurate, clear advice on feasibility
- To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trials
- To ensure MATTS (MedSCINets Active Trial Tracking System) requirements are meet
- To ensure confidentiality of commercially sensitive information.
- To ensure the General Data Protection Regulations requirements are met.
- To undertake such other duties within the scope of the post as may be requested by the Senior Clinical Trials Feasibility Associate or the Commercial Trials manager.
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.
This post will be a full time, indefinite contract.
Skills, knowledge, and experience
- Educated to degree level or possess equivalent relevant experience
- Experience of commercial clinical trial set up
- Knowledge of the regulatory requirements for clinical trials and GCP
- Knowledge and understanding of the commercial trial feasibility process
- Strong computer skills (proficient with MS word, Excel, and Web-based applications).
- Knowledge of medical, scientific and /or research terminology
- Demonstrably high levels of accuracy and attention to detail.
- Ability to explain complex ideas with clarity, and have excellent written and oral communication skills
- Sound judgment the ability to persuade people to their point of view without causing resentment or damaging working relationships.
- Experience conducting clinical trial feasibilities
- Direct, relevant work experience in field of clinical trials and sponsored research
- Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS.
- Knowledge, understanding and experience of the commercial/business environment clinical trials are conducted within
*Please note that this is a PhD level role but candidates who have submitted their thesis and are awaiting award of their PhDs will be considered. In these circumstances the appointment will be made at Grade 5, spine point 30 with the title of Research Assistant. Upon confirmation of the award of the PhD, the job title will become Research Associate and the salary will increase to Grade 6.*
The selection process will include a panel interview and assessment or presentation.
This post is subject to Disclosure and Barring Service
This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations and therefore the university will not be able to offer sponsorship for this role..