Study Specialist II

Study Specialist II

W2 Contract

Salary Range : $83,200 - $93,600 per year

Location : Novato, CA - Hybrid or Remote

Job Summary :

As a Study Specialist II, you will contribute to or lead tasks related to site monitoring, site management and / or vendor management, and other activities as delegated by the Study Manager. You will contribute to and support study-related matters that impact study timelines, quality, and budget.

Duties and Responsibilities :

• Develop and review study-specific documentation as delegated by the Study Manager.
• Contribute to the management of country and site feasibility assessment.
• Support managing 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.
• 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.
• Provide site management for delegated site(s).
• Manage and resolve site-related issues and escalated risks 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.

Requirements and Qualifications :

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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Desired Skills and Experience

Nursing, Health Sciences, Life Sciences, Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge, site management, vendor management, TMF

Salary : $83,200 - $93,600