Study Specialist - Talent Software Services : Job Details

Study Specialist Job Summary: Talent Software Services is in search of a Study Specialist for a contract position in San Rafael, CA(Hybrid San Rafael 2 days/week or Remote if >100 miles). The opportunity will be one year with a strong chance for a long-term extension. Position Summary: The Study Specialist II (SS-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: 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)
• Manage and resolve site related issues and risks escalated to client that can't be resolved by CRO.
• 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

Qualifications:

• 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.)
• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge
• Agility and Proactivity
• Communication and Collaboration

If this job is a match for your background, we would be honored to receive your application! Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!