Overview:
hVIVO are seeking a Cinical Trial Administrator to administer, maintain and co‑ordinate the logistical aspects of all hVIVO projects and act as a pivotal point of contact for the project teams and any vendor and affiliate organisations. they will assist Project Managers/Directors in co-ordinating and conducting clinical studies and trials in a manner that ensures quality, consistency, timeliness, accuracy and patient safety.
hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Clinical Trial Administrator reports to a Project Director, Project Management and works closely with the all members of the project team.
The role will be based in our London offices (E1).
- To provide general administrative support to the Project Management Department and assistance to Project Manager(s) and Project Director(s) i.e. filing and maintaining of the hVIVO Trial Master Files, coordinate meeting arrangements and conducting other administrative and logistical functions;
- To set up, organize and maintain clinical study documentation (e.g. hVIVO Trial Master File etc.) including preparation for internal/external audits, final reconciliation and archival;
- Assist in the tracking of the project progress and activities;
- To assist in the tracking and distribution of safety reports;
- Responsible for the preparation, handling and tracking of Ethics and Regulatory submissions, annual, safety and end of trial reporting, and facilitating any correspondence;
- Frequent face-to-face, written and telephone contact with various persons involved in the studies, including but not limited to laboratory staff, physicians, client sponsors, site staff, and all levels of hVIVO;
- Assist in maintaining and updating contact lists;
- Track essential documents and confirming ICH GCP compliance;
- Responsible for liaison with internal departments for regular progress updates;
- Support the Project Manager/Director in tracking and management of the project budget;
- Assist in coordination of project team and sponsor meetings – organise logistics, provide agenda, minutes and action points for meetings;
- Co-ordinate ordering/dispatch of project materials, as appropriate;
- Prepare and QC of Project Management sections of the Trial Master Files for archiving.
Essential
- Previous experience working in an admin support role in Project Management and/or an administrative support role in a clinial trials setting
- Qualified to degree level in Biomedical Sciences or similar
- Excellent written and verbal communication skills
- Good time management and organisational skills
- Enthusiastic
- Independant worker
- Ability to use initiative
- Able to adapt to changing priorities
Desirable
- Knowledge of ICH GCP/FDA regulations and relevant UK Statutory Instruments and EU Directives
