Jobs via Dice
Sr. Study Specialist // San Rafael, CA (Hybrid)
Jobs via Dice, San Rafael, California, United States, 94911
Sr. Study Specialist // San Rafael, CA (Hybrid)
We are seeking a Sr. Study Specialist (SS) to significantly contribute to or lead tasks related to site monitoring, vendor management, and other study activities. The role supports study participant safety, data integrity, timelines, quality, and budget.
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities
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
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
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
Education & Experience
BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets.
Contact Phone: Ext 301
Email:
[contact email]
368 Main Street, St #3, Melrose MA 02176
#J-18808-Ljbffr
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities
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
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
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
Education & Experience
BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets.
Contact Phone: Ext 301
Email:
[contact email]
368 Main Street, St #3, Melrose MA 02176
#J-18808-Ljbffr