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Senior Study Start Up & Regulatory Specialist

UK-London; UK-Marlow; UK-Eastleigh; Ireland-Dublin
Permanent
Reference: 046689
Description
Are you interested in improving your knowledge of Clinical Trials and contributing to our culture of process improvement with a focus on streamlining our processes of adding value to our business and meeting client needs?
 
Study Start Up Associate role within ICON:
 
Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.
 
Prepare, review and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
 
This includes, but it is not limited to:
 
Develop and finalize Country Specific SIS/ ICFs.
Prepare and finalize Country Specific xml files (if applicable for region).
Review and translate Drug Labels.
Perform independent quality review of submission packages.
Collect and maintain current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system.
Responsible for the translation and co-ordination of translations for documents required for submission (if applicable for region).
Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system.
Copy and route incoming correspondence, internal documentation, etc., as appropriate.
Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.
 
To succeed you will need:
 
A high school diploma or local equivalent, Bachelor’s Degree preferably in life sciences will ensure your familiarity with regulatory guidelines and industry knowledge. Minimum of 1 year of experience or understanding of clinical study start up requirements and activities.
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
 
*LI-PG1
 

 

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