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Study Specialist II

San Rafael, CA 94901

Posted: 02/16/2024 Employment Type: Contract Industry: Research and Discovery Job Number: 11589 Remote Friendly:

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.


Responsibilities include but are not limited to:
  • Develop and/or review study specific documentation, as delegated by the Study Manager.
  • Contribute to the management of country and site feasibility assessment.
  • Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites.
  • Contribute to the collection and oversight of essential documents for study life-cycle management.
  • Contribute to the development of site and investigator training materials.
  • May present at investigator meetings as assigned.
  • Ensure timely study entry and updates to ClinicalTrials.gov.
  • Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor).
  • Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted.
  • Facilitate Screening Authorization Forms tracking/sign off where applicable.
  • Manage various Global Study Operations document translations as applicable.
  • Process documents for signature in DocuSign.
  • Site management for delegated site(s).
  • Contribute to identifying risks identification and mitigations.
  • Oversee the Clinical Trial Insurance process.
  • Support Study Manager to ensure timely delivery and handling of IP to the sites.
  • Support Vendor Management.
  • Attend internal Global Study Operations team meetings, vendor meetings, 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.
  • Assist with filing GSO internal study documents in internal systems.

Job Requirements

Skills:
  • The Study Specialist II contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager.
  • This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget.
  • Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies.
Core Competencies:
  • Agility and Proactivity
  • Communication and Collaboration

Technical competencies:
  • Study Management and Execution
  • Compliance and Quality
  • Drug Development and Study Design
  • Product and Therapeutic Area Knowledge

Education and Experience:
  • BS or higher in nursing, life or health sciences is preferred 
    • Industry or relevant experience in lieu of education may be considered.
  • Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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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!