Sr Study Start Up Associate
About the role
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* Perform feasibility , site-identification ,site contract negotiation, and other study start up activities assigned
* ·Provide country specific Study Start Up expertise to Study Stan Up Team Leads and project teams.
* Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
* 'Develop, finalize and review Master and Country Specific Subject Information Sheet and Informed Consent Forms.
* Review and translate Drug labels
* 'Perform independent quality review of submission packages
* Perform timely and accurate data entry of all relevant Study Stan Up activities into the appropriate clinical trial management system
* Responsible for the timely follow-up of queries made by EC/CA
* Responsible for the collection of critical documents required for IP Release
* Responsible for the budget,negotiation execution and tracking of contract with sites.
*·Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee EC submission information and similar information for other related organizations,for the assigned countries.
*·To be familiar with ICH-GCP, and relevant country regulations/guidelines and ICON SOPs
* Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable
* Develop end maintain effective relationships with local,regional and country authorities
Role Requirements
- Bachelor's Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
- Global clinical trials experience with awareness of global regulatory requirements for clinical site initiation documents
- Proven experience handling study start ups for more than 2+ years
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin
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