The client 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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