Job Description
The King's Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King's College London, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is 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.
We wish to recruit a Clinical Trials Facilitator, who will be an integral member of the King's Health Partners Clinical Trials Office Commercial team. The post holder will act as the initial key contact within KHP-CTO for all researchers, commercial companies and contract research organisations wishing to undertake commercial clinical trials within our Partner Organisations and support the set up and administration of a portfolio of commercial clinical trials.
The King's Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King's College London, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is 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.
This post will be offered on an indefinite contract. This is a full-time post - 100% full time equivalent
Key responsibilities
- Facilitate the collection and preparation of documentation required to confirm local capacity, obtain R&D theme lead approvals, collate regulatory approvals needed to instigate clinical trials
- Facilitate the collection of local and regulatory approvals required for the review and implementation of amendments
- To work closely with Finance and Research Teams to ensure the timely invoicing of commercial trials
- Provide comprehensive advice to external and internal parties for the conduct of clinical trials across the partner organisations.
- To assist in maintaining records of the clinical trials portfolio of the partner organisations
- To ensure that trails metrics are collected to permit tracking of milestones and, where appropriate, to coordinate the triggering of invoicing to sponsors.
- To assist int he archiving of clinical trails and documentation to meet prevailing regulatory requirements.
- To ensure MATTS (MedSciNets Active Trial Tracking System) end EDGE requirements are met
- To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trials
- To ensure confidentiality of commercially sensitive information
- To ensure data protection imperatives are respected
- To undertake such other duties within the scope of the post as may be requested by the SCTF
The above lost 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
- Strong planning and organisational skills including the ability to prioritize and manage multiple tasks
- Excellent interpersonal skills - tactful and able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining polices and regulations
- Problem soloing skills - pragmatic and flexible approach whilst maintaining policies and regulations
- Strong computer skills (proficient with MS WORD, Excel and web - based applications)
- Commitment to quality culture
- A professional demeanor and high ethical standards
- A proactive approach
- Ability to understand function in the different cultural environments of academics and clinical academia
- experience acquired in administration role(s), preferably in either a pharmaceutical industry of clinical research setting
- Understanding of medical terminology and practice
- Knowledge of GCP and full working knowledge of local regulatory requirements for the conduct of clinical trials
- Understanding of Ethics committees and competent authority approval processes
- Specific experience of clinical trial administration