Study Specialist I, Global Study Operations

Study Specialist I, Global Study Operations Job ID: 24-02490 THIS ROLE IS HYBRID AND REQUIRES WORKING IN SAN RAFAEL A MINIMUM OF 2 DAYS PER WEEK

The

• 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.

Role 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.

Activities and responsibilities may include:

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

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

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