Study Specialist

Are you an experienced Study Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Study Specialist to work at their company in San Rafael, CA.

Position Summary: The Study Specialist I (SS I) is 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. The client's Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Primary Responsibilities/Accountabilities:

• 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

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