Sr. Study Specialist
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Job Location:
San Rafael, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Title: Sr. Study Specialist
Location: San Rafael CA (Hybrid - 2 days per week)
Duration : 12 months.
Role Summary
The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring vendor management and other activities as delegated by the Study Manager or Program Lead (PL).
Technical Competencies:
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
- Develop study specific documentation as delegated by the Study Manager
- Contribute to the oversight of country and site feasibility assessment and site selection.
- Oversight of CRO for IRB/EC related submission/approval activities
- Oversight of essential documents for study life-cycle management
- Develop/Oversee site and investigator training materials
- Present at investigator meetings as assigned
- Ensure accurate and timely study entry and updates to
- Facilitate Screening Authorization Forms sign off and oversee tracking where applicable
- Process documents for signature in DocuSign
- Oversight of Clinical Trial Insurance
- Attend Global Study Operations team vendor and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
- Oversee and manage essential documents in the Trial Master File (TMF)
- Contribute to Global Study Operations risks identification and mitigations.
- Provide support and administrative assistance with internal and external meetings
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
