Abbott Clinical Study Start-Up Coordinator in United States
The UK Legacy St. Jude Medical Clinical team are recruiting for the newly created position of Clinical Study Start-Up Coordinator, to provide administrative support to the the Clinical team, supporting study start up and submission activities.
The successful individual will collaborate with the existing Clinical Project Leaders and wider team regarding study or site management, and be responsible for study start up and submission activities including:
Preparing documents for Ethics Committee/Competent Authority (EC/CA) submission;
Interpreting clinical study protocols in order to support IRAS application where layman terms are required;
Point of contact of EC/CA;
Attends EC meetings if deemed appropriate by Supervisor/CPL;
Adapt study budget for local R&D submission/approval;
Work with local Radiation Protection Officers within the Trust;
Prepare submission to any other authority when applicable;
Set-up and maintain study regulatory binders to ensure documents are compliant for audit purposes.
The Clinical Study Start-Up Coordinator will also support the preparation of study agreements, including negotiating study agreements and liaison with the Study Manager/CPL for budget re-evaluation, and provide support to the Clinical Project Teams, such as the development and review of informed consent document/patient information sheet and assisting with collection of site activation documents.
It is expected that this individual will be office-based (Shirley, Solihull) 1-2 days per week typically.
Ideal candidates will hold a BSc combined with experience in clinical research or related devices/pharmaceutical experience or clinical experience in a clinical/hospital environment. A general familiarity with cardiac, vascular and/or neuromodulation technologies, as well as clinical research processes is desired.
Clinical Affairs / Statistics
ASJM Abbott St. Jude Medical
United Kingdom : Capulet House Stratford Business & Technology Park Banbury Rd
Yes, 50 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Work with or near radiation sources and/or radioactive material
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