Clinical Trials Facilitator
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.
This post will be offered on an indefinite contract for X years/months. This is a full-time post - 100% full time equivalent
- Facilitate the collection and preparation of documentation required to confirm local capacity, obtain RED 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 trials metrics are collected to permit tracking of milestones and, where appropriate, to coordinate the triggering of invoicing to sponsors.
- To assist in the archiving of clinical trials documentation to meet prevailing regulatory requirements.
- To ensure MATTS (MedSciNets Active Trail Tracking System) and EDGE requirement are met
- To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trails
- 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 list of responsibility may not be exhaustive 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 mange multiple task,
Excellent interpersonal skills - tactful and able to deal with wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations.
problem solving skills - Pragmatic and flexible approach whilst maintaining polices 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
Ability to understand and function in the different cultural environments of academics and clinical academia • Experience acquired in administration role(s), preferably in either a pharmaceutical industry or 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 trails
understanding of ethics committees and competent authority approval processes
specific experience of clinical trail administration
If you have any questions please contact Merve Demirol - firstname.lastname@example.org