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Clara Johnson

Clara Johnson

Clinical Research Associate

Boston Scientific

Clinical Studies Professional with a BA in Professional and Organizational Communication Studies in addition to clinical, customer service, administrative, leadership, communication and project management experience. Specialties: Experience in Microsoft Office Suite, including Publisher and Access, Adobe; Macintosh Software;...

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Boston Scientific

Clinical Research Associate

• Responsible for the development and distribution of Investigator Site Files (Regulatory Binders)
• Employed prioritization, time management and multi-tasking skills to successfully manage multiple sites in essential start up activity while continuing to support existing sites with any site maintenance
• Utilized time management, informed consent knowledge and attention to detail to successfully negotiate a complete site specific Informed Consent template
• Employed management skills to track all site IRB/EC registrations, submissions, approvals and renewals
• Responsible for Research Agreement and Budget negotiations and amendments
• Ensured essential document collection needed for site authorization and used Site Start Up Checklist to manage and monitor site progress
• Managed site authorization to enroll activities and communications
• Distributed any questions to Medical Expert, Field personnel or Project Manager as appropriate
• Managed contact and accounts in CTMS including any staff changes, new sites, etc.
• Successfully transitioned into Clinical Research Associate role while providing continued Clinical Trial Clinical Research Organization support
• Provided expertise to the Trial Operations team as the Clinical Trial Specialist Subject Matter Expert including my proficiency in CDC and CTMS systems and experience with trial materials
• Responsible for site and budget audits for my region
• Responsible for all site filing of hard copy documents for my region
• Responsible for all access requests to the clinical trial storage room

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