Senior Clinical Research Associate

Key Duties and Responsibilities

• Conduct regular monitoring visits to ensure the trial is conducted in accordance with the protocol and that subject safety is maintained.
• Verify data accuracy through comprehensive Source Document Verification (SDV).
• Ensure investigational products, biological samples, and study supplies are handled according to applicable requirements, including receipt, storage, return, destruction, and accountability.

Trial Master File (TMF) and Documentation Management

• Maintain the electronic and/or paper Trial Master File (TMF) to ensure proper documentation standards are met and tasks are performed independently.
• Affiliate in the creation, distribution, management, and archiving of essential clinical trial documents.

Site Materials and Training Support

• Affiliate in the preparation and maintenance of study-related materials, including but not limited to site and CRA training materials, regulatory document templates, study binders, study plans, communication records, and presentation materials.
• Support training activities for clinical research teams and site staff.

Site Contracts and Vendor Support

• Affiliate in the execution and management of site-related contracts.
• Affiliate in the review of vendor and site contract terms and verify associated invoices for accuracy and compliance with budget.

Compliance with Regulatory and SOP Requirements

• Ensure all responsibilities are carried out in compliance with company regulations, safety policies, and standard operating procedures (SOPs).

Clinical Trial Operational Oversight

• Manage all operational aspects of clinical trials, from Study Start-up through Database Lock.
• Ensure all activities adhere to stated goals, timelines, budgets, and strictly comply with applicable regulatory requirements, ICH/GCP, and Standard Operating Procedure (SOP) standards.
• Provide sponsor oversight of the CRO activities for the Global Phase 3 trial.

Vendor and Stakeholder Management

• Vendor Management and Oversight: Responsible for the overall management and oversight of all study-related vendors, including Contract Research Organizations (CROs) and Contract Labs.
• Contracting, Procurement, and Finance: Review and provide input on vendor contracts and Statements of Work (SOWs).
• Affiliate in invoice reconciliation and financial tracking, as needed.
• Communication and Issue Resolution: Serve as the primary point of contact for key vendors and stakeholders. Responsible for managing and coordinating parties to effectively facilitate issue resolution.

Other Duties

• Other duties as mutually agreed between the candidate and the company.