Clinical Study Specialist

Study Specialist I, - Global Study Operations

1 Year (Extendable)

San, Rafael, CA - Hybrid - Onsite 2 days / week

Max PR: $25-32/hr

Job Summary

The Study Specialist I (SS I) responsible to complete tasks related to the administrative support of study teams and department members and efforts. The SS I is not allocated as a resource to any specific study or program. Administrative tasks and activities may be requested by a line manager, study team member, or GSO department staff. Assignments may include contributing to or supporting teams as an ad-hoc or SWAT resource and in some cases may require line manager approval depending on level of effort and/or duration.

Job Responsibilities

• BOARD Quarterly MVR GSO Compliance and other metrics
• SRDO Program Roster updates and maintenance
• GSO Department Website maintenance
• Knowledge Manager; responsible for maintaining the department website, GSO Dept Teams locations, and reconciling/filing between Teams and the GSO SharePoint Content Center
• The below tasks may also be included when unsupported by study staff and/or CRO:
• eTMF and SharePoint/Teams documents; may include upload, correction, review, and reporting
• Clerical assistance to arrange internal/external meetings and teleconferences
• Process documents for DocuSign signatures (e.g., facilitate and/or support IP package review/signatures, ICF signatures)
• Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archival
• Support mass communications via email or mailings

Education & Qualifications 

• Relevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skills,
• Proficient in MS Suite; Excel, Word, Outlook, Zoom, and Teams