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Study Specialist I, Global Study Operations - San Rafael, United States - Intelliswift
Description
Job ID:
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 SummaryThe 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
