Study Delivery Administrator

STUDY DELIVERY ADMINISTRATOR

Contract: 11 months

Location: Luton

Remuneration: Competitive

THE ROLE

The Study Delivery Administrator contributes to the achievement of Clinical Research objectives by:

- Coordinating and delivering the administrative Study Delivery (SD) activities within the Study Delivery Team (SDT) as required by each study, to ensure maintenance of relevant systems, and quality and consistency of SD deliverables to time, cost and quality objectives
- comprehensive management and archiving of study documentation

KEY ACCOUNTABILITIES

- Proactive management of all Administrative aspects of the set up and conduct of clinical trials within UK study sites, and delivery of the associated study milestones, targets and activities within the allocated resource/time
- Collaboration with the Clinical Project Leader, Clinical Administration Manager, other SDAs, Clinical Research Managers, and the Clinical Research Associates to ensure that quality and quantity commitments are achieved in a timely and efficient manner
- Maintain systems tracking sheets as required for allocated studies
- Collect, assist in preparation, review and tracking of documents for the application process (RA/IEC). Interface with Investigators, CROs and CRA´s (MCs in case of international studies) during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs and/or the Clinical Project Leader until finalization of the study.
- Manage the receipt and tracking of data
- Responsible for the day to day operation and maintenance of document management systems (eg scanning etc), and to train others as required.
- Create Purchase Orders for study payments
- Resolve payment queries from customers
- Assist Clinical Project Leader with MREC submission, including coordination of the documentation and the addition of site-specific information, non-study specific answers & completion of the checklist
- Be responsible for site drug release/site approval process ensuring all critical documents and full approvals are in-house prior to Impact Initiation Date
- Manage and contribute to coordination and tracking of study materials and equipment. Arrange dispatch of study drug and non-drug supplies to sites
- Lead the practical and administrative arrangements and contribute to the preparation of internal and external meetings eg study team meetings, monitor meetings, Investigator meetings.
- Collateability to respond quickly to shifting demands and opportunities

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