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Clinical Trial Associate
Ref No.: 18-13917
Location: San Rafael, California
Summary Description
The Clinical Trial Assistant (CTA) performs essential responsibilities for successful trial execution at BioMarin. The CTA assists with the coordination of activities associated with the start-up, management, and close-out of clinical studies under the direction the Clinical Operations team. This may include assisting with study matters that impact study timelines, quality and budget.
Key Responsibilities
The Clinical Trial Assistant can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:
Quality:
Create/maintain essential document trackers
Conduct comprehensive review, as per Trial Master File (TMF) Plan
Provide continuous input to electronic Trial Master File (eTMF) content list
Assist with Clinical Operations internal filing of study documents
Contracts & Budgets:
Facilitate the initiation and maintenance of the Clinical Trial Agreements, contract execution, vendor purchase orders
Clinical Operations Managed Vendors & CRO:
Reconciliation & management of key documents (plans, site contact list, etc.)
Assist in any purchase order (PO) related inquiries
Ensure vendor PO contains funds for insurance and translation vendors

The Clinical Trial Assistant is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Analysis, Problem solving and Decision Making. For example:
Responds promptly with clear, organized written and oral communication
Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
Study Start Up:
Provide administrative assistance with internal and external meetings including investigator meeting(s)
Request and distribute insurance policy/certificates (see Insurance section)
Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)
Ensure accurate study entry and updates to ClinicalTrials.gov
Study Conduct and Close-out:
Ensure MVR tracking and filing of sponsor comments
Identify issues, with potential resolution, and escalate when appropriate
Assist in the conduct of study close-out activities (sites, reconciliation activities, filing & archiving)
Track and collate clinical trial documentation related to CSR appendices
The Clinical Trial Assistant is also assisting in insurance and investigational product related activities