Clinical Trial Associate

Key Responsibilities

• Actively engages in site management activities, including assisting with site regulatory startup (including ICF review), providing oversight for site-level IRB submissions, managing site communications, and conducting onsite or remote investigator site file (ISF) reviews.
• Ledds meeting coordination activities, including preparing agendas, facilitating discussions, and documenting key decisions and action items.
• Provides support for site training by presenting GCP/GDP requirements, study-specific logs, and ISF expectations to ensure alignment with protocol and regulatory requirements.
• Supports coordination of Investigational Products (IP), focusing on the documentation and tracking.
• Tracks and reports on key study metrics (e.g., regulatory package status, TMF accuracy/completeness/quality, site statuses) and provides regular updates to leadership with proposed mitigation strategies.
• Serves as the primary point of contact for inspection readiness and audit preparation by conducting internal reviews, preparing team members, and participating in mock audits to ensure a continuous state of readiness.
• Maintains and organizes TMF, including identifying and resolving TMF gaps, ensuring documents are complete, accurate and inspection ready.
• Contributes or authors key study documents, including Informed Consent Form (ICF)/Assent, study plans, and study-related templates.
• Supports CRAs in monitoring visit execution by performing eISF reviews and providing TMF vs ISF reports to ensure completeness.
• Manages day-to-day interactions and deliverables for third-party vendors (e.g., central labs, imaging) to ensure adherence to study timelines.
• Reviews vendor-specific documentation for accuracy and ensures relevant records are filed in the TMF.
• Contributes to departmental operations and process improvements, including SOP authorship, development of templates and tools, and optimization of systems.
• Manages Central IRB activities across programs, including submission oversight, tracking approvals, and maintaining cross-functional IRB trackers.
• Performs contractual management, PO management, invoice tracking, and site payments.
• Performs Protocol Deviation management, data review, medical review committee submission management, and ClinicalTrials.gov maintenance.
• Captures planning for Investigator Meetings and specialized Surgeon Training.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field (e.g., Biology, Nursing, Pharmacy).
• Minimum 2+ years of experience in clinical research or clinical operations.
• Strong understanding of regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations).
• Experience specifically within a pharmaceutical or biotechnology sponsor environment (given the internal focus of the role).