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