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Sr. Study Specialist

San Rafael, CA 94901

Posted: 11/04/2025 Employment Type: Contract Industry: Medical Affairs Job Number: 12430 Pay Rate: $55.00 - $65.00 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.

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:

Core Competencies:
  • Agility and Proactivity
  • Leadership
  • Communication and Collaboration
  • Technical Competencies:
  • Study Management and Execution
  • Compliance and Quality
  • Drug Development and Study Design
  • Product and Therapeutic Area Knowledge

Responsibilities include but are not limited to:
  • Develop study specific documentation, as delegated by the Study Manager
  • Contribute to the oversight of country and site feasibility assessment and site selection.
  • Oversight of CRO for IRB/EC related submission/approval activities
  • Oversight of essential documents for study life-cycle management
  • Develop/Oversee site and investigator training materials
  • Present at investigator meetings as assigned
  • Ensure accurate and timely study entry and updates to ClinicalTrials.gov
  • Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
  • Process documents for signature in DocuSign
  • Oversight of Clinical Trial Insurance
  • Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
  • Oversee and manage essential documents in the Trial Master File (TMF)
  • Contribute to Global Study Operations risks identification and mitigations.
  • Provide support and administrative assistance with internal and external meetings

Job Requirements

Education & Experience:
  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered
  • Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets

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!