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Clinical Trial Administrator
Reports To:
Clinical Operations Head
Location:
Office based in Oxford
Main purpose of job:
To assist with the clinical activities to support the Vaccitech portfolio of research and development
projects. All activities carried out with regard to time, cost and quality and in accordance with
SOPs, ICH/ GCP guidelines and local regulations.
Key responsibilities include:
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Preparing essential clinical trial documents
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Tracking, distributing and filing documents when they are returned
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Maintaining the electronic Sponsor Oversight File and/or the Trial Master File (TMF)
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Preparing and sending study materials to investigator sites
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Management of key study related meetings including; agenda preparation, arranging
meeting logistics and taking of and distribution of minutes
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Arranging investigator meetings
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Tracking and processing investigator site payments
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Raising purchase orders to pay investigator sites
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Supporting clinical research staff within the department
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Coordination of the translation of key patient facing documents
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Managing trial supplies
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Facilitating coordination of ethics, country-specific regulatory and research and
development (R&D) submissions
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Initial composition of Investigator Site File (ISF)
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Creating and maintaining study contact lists for study team and sites
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Setting up mail merges
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Archiving documents
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Sending study newsletters to sites
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Assisting with the management of safety including SUSAR reporting
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Organising accommodation and flights regarding IM meetings, site visits etc
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Understanding of trackers and formulas
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Quality checking CRO eTMF systems and flagging any findings to the relevant person
Personal Abilities and Traits:
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Demonstrates personal drive and goal orientation.
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Self-motivated taking personal pride in delivering on personal and corporate objectives.
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Enthusiastic and flexible to change.
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Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
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Able to interact with individuals at all levels of the organisation.
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A highly effective communicator, both orally and in writing with an eye for detail/ accuracy
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Reliable and trustworthy, able to work with minimal supervision.
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Ability to work well on own as well as being part of the team
