Study Specialist II, Clinical Trials Operations

Location: San Rafael, CA. (Hybrid 2 days on-site)

12 month assignment (great potential to extend)

Pay Rate: $40-$45/hr. DOE

On behalf of our client a global leader in advancing therapeutics for rare genetic diseases. The Study Specialist II provides essential support in clinical trial site monitoring, site management, and vendor coordination under the guidance of the Study Manager. This role is instrumental in maintaining study timelines, quality standards, and budget compliance, with responsibilities spanning documentation, training, and regulatory support.

Key Responsibilities

• Develop and review study-specific documents as assigned.
• Assist with regulatory document collection and tracking.
• Oversee and manage essential study documents throughout the study life-cycle.
• Contribute to site and investigator training materials.
• Provide administrative assistance for internal and external meetings.
• Manage designated study sites, including issue resolution.
• Support the Study Manager with Investigational Product logistics to sites.
• Ensure timely investigator payments, collaborating with payment vendors.
• Support the management and oversight of external vendors, including CROs, labs, and other partners.
• Ensure timely entry and updates to ClinicalTrials.gov.
• Process document signatures in DocuSign.
• Oversee essential documents within the Trial Master File (TMF).
• Monitor risk identification and mitigation processes for Global Study Operations.
• Ensure clinical trial insurance requirements are met.

Education & Experience

• Bachelor’s degree or higher in Nursing, life sciences, or health sciences and 3 + years of experience or relevant clinical trials experience.
• Proven experience managing external vendors (CROs, central labs, imaging vendors, etc.) is required.