Senior Study Start Up Associate
About the role
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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?
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.
Prepare and finalize Country Specific xml files (if applicable for region).
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.
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.
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.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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