Clinical Research Associate II
King's College London
- Strand, Central London
- £43,205-50,585 per year
- Permanent
- Full-time
- Set up, monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance.
- Provide support to investigators conducting clinical trials sponsored by partner institutions to ensure they are working to the highest quality standards and to monitor and report on the progress of trials.
- Ensure that investigators and their teams run trials according to sponsor's SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out monitoring functions as appropriate.
- To assist the Quality Manager (QM) and R&D staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the current UK and EU Clinical Trial legislations and the KHP-CTO SOPs.
- To ensure that development safety update reports, pharmacovigilance reports and protocol amendments are submitted to MHRA, thereby maintaining Clinical Trial Authorisations To set up, initiate, monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Activities to include:
- To assist the QM in the conduct of regulatory inspections and sponsor audits for both commercially sponsored and non-commercially sponsored trials on behalf of the partner institutions.
- To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.
- To provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions.
- To promote a quality approach to the conduct of clinical trials and act as an ambassador for the KHP-CTO
- This post is field based with regular national and, on occasion, international travel including overnight stays
- Educated to “A” level or degree level, preferably in a related subject area, e.g. a life science or clinical subject
- Sound working knowledge of the prevailing regulations and best research practices pertaining to the conduct of clinical trials, in particular GCP
- Strong planning and organisational skills including the ability to prioritise, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria.
- Strong interpersonal, communication, influencing and problem-solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment
- Strong computer skills (proficient with MS WORD, Excel and web-based applications).
- Eye for detail and ability to accurately document findings in written reports
- Able to learn and work to SOPs and demonstrate a commitment to quality culture
- A flexible, self-starter who is comfortable working with all levels of staff internally and externally.
- Experience and knowledge of working within the NHS Research Governance Framework.
- Experience of setting up and closing down clinical trials within the NHS/academic sector or within a pharmaceutical company
- Ability to understand and function in the different cultural environments of clinical research