Study Start -Up Specialist II
China, Remote 求人ID R0000028838 Category Clinical TrialsAbout this Role
Key Accountabilities:
Start-up (from site identification through pre-initiation):
• Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned. Distribute and collect DAs for potential study sites.
• Provide country-specific study start-up expertise to study start-up team leads and project teams. Create study start-up document templates.
• Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs.
• Review and translate drug labels. • Perform independent quality review of submission packages.
• Responsible for the translation and coordination of translations for documents required for submission.
• Perform timely and accurate data entry of all relevant study start- up activities into the appropriate
• CTMS.
Skills:
Proven organizational and presentation skills.
Ability to manage multiple tasks and meticulous attention to detail.
Agile & quick learner, good team player
Willingness and ability to train others on study administration procedures. • Excellent written and verbal communication skills.
Good written and spoken English.
Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint, and Outlook, etc.
Knowledge and Experience:
1 - 2 years of experience required.
Read, write, and speak fluent English; fluent in host country language may be required.
Education:
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.
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