Abbott Clinical Study Start-Up Coordinator in United States

JOB DESCRIPTION:

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;

  • NIHR adoption;

  • 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.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United Kingdom : Capulet House Stratford Business & Technology Park Banbury Rd

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

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

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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