What are the responsibilities and job description for the Study Specialist II position at Talent Software Services?
Role Summary
The Study Specialist II contributes to or leads tasks related to the oversight of site monitoring, site management, and / or vendor management, along with other activities as delegated by the Study Manager. This role involves supporting study-related matters that impact study timelines, quality, and budget. The candidate is expected to demonstrate proficient knowledge and experience in the following competencies :
Agility and Proactivity
Communication and Collaboration
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities
Develop and / or review study-specific documentation as delegated by the Study Manager.
Contribute to the management of country and site feasibility assessment.
Support the management of Regulatory document collection and tracking for participating sites.
Oversee the collection of essential documents for study life-cycle management.
Contribute to the development of site and investigator training materials.
Present at investigator meetings as assigned.
Ensure timely study entry and updates to ClinicalTrials.gov.
Ensure investigator payment, including site set-up, processing, and funding in collaboration with the payment vendor.
Provide administrative assistance for internal and external meetings, including investigator meetings.
Facilitate Screening Authorization Forms tracking and sign-off where applicable.
Manage various document translations as applicable.
Process documents for signature in DocuSign.
Manage site-related issues and risks escalated that cannot be resolved by CRO.
Contribute to identifying risks and mitigations.
Oversee the Clinical Trial Insurance process.
Support the Study Manager to ensure timely delivery and handling of IP to the sites.
Support Vendor Management.
Attend internal meetings, vendor meetings, and / or Cross-Function Study Execution Meetings as a 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.
Assist with filing internal study documents in internal systems.
Education & 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.)
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