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Study Specialist I

San Rafael, CA 94901

Posted: 07/02/2025 Employment Type: Contract Industry: Administration Job Number: 12219 Pay Rate: $30.00 - $33.00 Remote Friendly: Onsite

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Role Overview: 

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.

Duties:
  • 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

Job Requirements

Education & Experience:
  • Relevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skill
  • Proficient in MS Suite; Excel, Word, Outlook, Zoom, and Teams

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!