Study Specialist II

$80,101 - $94,245/Yr

Randstad - San Rafael, CA

Full-time - Entry Level

San Rafael, CA

Administrative and Support Services

About the position

The Study Specialist II (SS-II) plays a crucial role in the oversight of site monitoring, site management, and vendor management within the life sciences sector. This position is designed for individuals who are eager to contribute to study-related tasks that impact timelines, quality, and budget, while also providing administrative support to the Study Manager. The role requires a blend of agility, proactivity, and strong communication skills, along with technical competencies in study management and compliance.

Responsibilities

• Develop and/or review study specific documentation, as delegated by the Study Manager.
• Contribute to the management of country and site feasibility assessment.
• Provide support in the management of Regulatory document collection and tracking for participating sites.
• Contribute to the collection and oversight of essential documents for study life-cycle management.
• Contribute to the development of site and investigator training materials.
• May present at investigator meetings as assigned.
• Ensure timely study entry and updates to ClinicalTrials.gov.
• Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing.
• Provide administrative assistance with internal and external meetings including investigator meeting(s).
• Facilitate Screening Authorization Forms tracking/sign off where applicable.
• Manage various Global Study Operations document translations as applicable.
• Process documents for signature in DocuSign.
• Site management for delegated site(s).
• Manage and resolve site related issues and risks escalated to BioMarin that can't be resolved by CRO.
• Contribute to identifying risks identification and mitigations.
• Oversee the Clinical Trial Insurance process.
• Support Study Manager to ensure timely delivery and handling of IP to the sites.
• Support Vendor Management.
• Attend internal Global Study Operations team meetings, vendor meetings, 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.
• Assist with filing GSO internal study documents in internal systems.

Requirements

• BS or higher in nursing, life or health sciences is preferred.
• Industry or relevant experience in lieu of education may be considered.
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).
• Proficient knowledge and experience in study management and execution, compliance and quality, drug development, and study design.

Nice-to-haves

• Experience in vendor management and regulatory affairs strategy.

Benefits

• Health insurance coverage
• 401K contribution
• Incentive and recognition program