Clinical Study Administrator

4 days ago

London, United Kingdom hVIVO Services Limited Full time

Overview:
hVIVO are currently seeking a Clinical Study Administrator (CSA) to maintain and co‑ordinate the logístical and documentational aspects of all hVIVO projects.

hVIVO conducts human challenge clinical trials. 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 CSA will act as a pivotal point of contact for the clinical study team, assist the Clinical Study Leads, Nurses and Principal Investigators in co-ordinating and conducting clinical studies and trials ensuring quality, consistency, timeliness, accuracy and patient safety.

Main Responsibilities:

- To provide general administrative support to the site study team;
- To be a part of the core study team and take part in completion of all required tasks to meet departmental and project objectives;
- To support the Clinical Study Leads, study nurses and Principal Investigators in performing the administrative and logístical tasks of the project(s) i.e. filing and maintaining of hVIVO study specific documents, coordinate meeting arrangements and conducting other administrative and operational functions;
- To set up, organize and maintain clinical study documentation (e.g. hVIVO Investigator Site File etc.) including preparation for monitoring visits, internal/external audits and archiving;
- Assist in the tracking of the project progress and activities;
- To assist in the tracking and distribution of study specific documents or reports;
- Frequent face-to-face, written and telephone contact with various persons involved in the studies, including but not limited to laboratory staff, physicians, site staff, and all levels of hVIVO.
- Knowledge of ICH GCP/FDA regulations, relevant UK Statutory Instruments and EU Directives and relevant Company SOPs; and
- Knowledge of various project protocols, and other project documentation.

Skills & Experiences:

- Experience working in an admin support role
- Research or health care related academic or work experience preferable
- Ability to work on own initiative
- Good written and spoken communication skills, ability to communicate ideas clearly and effectively
- Good organisational skills, ability to manage multiple tasks and meticulous attention to detail
- Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook

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