Study Coordinator Jobs

Title: Study Specialist I, Global Study Operations

Location: 2 days onsite per week in San Rafael, CA 94903

Duration: 12 months assignment

THIS ROLE IS HYBRID AND REQUIRES WORKING IN SAN RAFAEL A MINIMUM OF 2 DAYS PER WEEK

:

• Client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. Client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Client therapeutics, advancing the standard of care, and providing personalized support and services globally.
• 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 SS I is not allocated as a resource to any specific study or program.
• The Study Specialist I (SS I) responsible to complete tasks related to the administrative support of study teams and department members and efforts.
• 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.
• Administrative tasks and activities may be requested by a line manager, study team member, or GSO department staff.

Activities and responsibilities may include:

• SRDO Program Roster updates and maintenance
• BOARD Quarterly MVR GSO Compliance and other metrics
• 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:

• Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archival
• Clerical assistance to arrange internal/external meetings and teleconferences
• Support mass communications via email or mailings
• ETMF and SharePoint/Teams documents; may include upload, correction, review, and reporting
• Process documents for DocuSign signatures (e.g., facilitate and/or support IP package review/signatures, ICF signatures)

Skills:

• 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