Clinical Trial Administrator Job in Oxfordshire, Home Counties Uk

Title: Clinical Trial Administrator - Must have at least 1 year UK pharmaceutical industry experience in an administrative role

Company Profile:

Key People are working with small niche CRO company specialising in early phase research to offer an experienced CTA the opportunity to join join their small, closely knit team in Oxford.

The Role:

•To understand the protocol and therapeutic area in sufficient detail to advise and discuss with the study team and study site personnel when requested.
•To remain up to date with all relevant SOPs and regulatory requirements.
•To organise, draft and circulate minutes of the project team meetings (both internal project team meetings and project team meetings with the sponsor).
•To coordinate project related face to face meetings with the sponsor and other project team members.
•To coordinate investigator meetings (if applicable).
•To set up and maintain tracking tools for the project team, including but not limited to, investigator site selection tracking, collection of all study related documents (e.g. confidentiality agreements, investigator contracts and regulatory documents), tracking of site status during the set-up phase, tracking of participant recruitment, tracking of Serious Adverse Events, tracking of protocol waivers and violations).
•To assist with protocol review, if requested.
•To assist with CRF review, if requested.
•To aid the project team members in preparation for site selection visits.
•To help the project team members prepare initiation visits.
•To assist the project team members in preparation for monitoring visits.
•To help the project team members prepare close-out visits.
•To set-up and maintain Investigator study files.
•To coordinate the filing and archiving of all relevant documentation for the study in order to comply with the relevant SOPs and regulations.
•To act as a contact point for the sponsor in the absence of the Clinical Project Manager.
•To act as the contact point for the investigator sites in the absence of the Clinical Project Manager.
•To conduct other tasks related to the project as requested by the Clinical project manager and other project team members.
•To help the project team members prepare regulatory submissions.
•To help the project team members prepare ethics submissions.
•To conduct other administrative tasks as required by the Clinical Operations team.

The Person:

•Graduate with Life Sciences or scientific equivalent degree
•Excellent communication skills (both written and oral)
•Proactive contribution towards the team by being a flexible team player
•Ability to motivate others
•A concern for quality, attention to detail and accuracy
•Ability to multi-task and problem solve
•Ability to work independently in a fast-paced environment
•Good organisational, computer and administrative skills
•1 or 2 years experience as a Clinical Trial Administrator
•Good working knowledge of ICH-GCP

For more information please contact:

Adam Griffin
agriffin@keypeople.co.uk
+44 1727 817 648

"CTA" "clinical trial assistant" "clinical project assistant" "pharmaceuticals" "clinical research"