Study Start Up Associate II
About the role
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- As a member of staff, the employee is eJ(pected to embrace and contribute to our culture or process improvement with a focus on streamlining our processes adding value to our business and meeting cltent needs
- Travel (approiximately 15%) domest and/or international.
- Anticipated activities may tnclude attendance at Bid Defences,Kick-Off,Investigator or study team meetings
- Perform feasibility , site identification ,site contract negouatron, and other study start up activities. as 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 revrew Master and Country Spec.fie Subject Information Sheet Inform Consent Forms (SISlCF).
- Prepare. ·finaftze and relliew Master and Country Specific EU ClinJcal Trial Application Forms and corresponding data files in collaboration with other relevant departments (xml file) (EU Only).
- Review and translate Drug labels
- Perform independent quality review of submission packages
- Responsible for the translation and co-ordination of translations for documents required for submission.
- Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate cbnical trial management system
- Copy and routeincoming correspondence internal documentation.etc ,as appropriate
- Respons!ble for the timety follow-up for queries made by EC/CA
- Responsible for the collection of clinical documents required for IP Release
- Responsible for the dJSpa:cn,negotiation execution and tracking of contract with sites and other srtn. as appropriate.
- Responsible for the timely and accurate data entry of all relevant Study Start Up acttivities into the appropnate clinical trial management system in assigned countries
- Attend study team mttngs as required. including Kick-Off Meeting
- Assemble and distnbute study materials to Clinical and Project teams.
- Including matenals to study sites andInvestigator Meetmgs (e g : investigator binders) and vendors.as appropriate.(US only)
- Responsible for the collection and maintenance of the current Regulatory/Competent Authonty (CA) and Ethics Committee EC submission information and similar informations
- To be famUiar withICH GCP, relevant country regulations/guidelines and ICON SOPs
- Competent in communication and tnfluenc1ng skills to ensure timely follow-up. issue resof\Jhon and report updates,as outlined 1n the communrcat1on and escalation plan with timely documentation
- Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable
- Develop end matntain effective relationships with local,regional and country authoritres
- Comply with all department requirements regarding information provision and status updating and reporting
- To undertake and fulfill Study Start Up Team Lead role activitieses as per the Study Start Up ream Lead scope defmftion 10 preparat on for future career progression 10 Study Start Up Team Lead
- To undertake other reasonably related duties as may be assigned
Application process
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