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Sr. Study Specialist

Compass Consulting

San Rafael, CA

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JOB DETAILS
SKILLS
Administrative Skills, Budgeting, Clinical Study Publications, Clinical Trial, Contract Research Organization (CRO), Cross-Functional, Data Quality, Document Management, Documentation, Feasibility Analysis, Genetic Diseases, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Insurance, Meeting Minutes, Relationship Management, Risk Analysis, Risk Management, Sales Management, Site Evaluation, Time Management, Vendor/Supplier Management
LOCATION
San Rafael, CA
POSTED
30+ days ago
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 Summary:

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:


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

About the Company

C

Compass Consulting

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