Clinical Research Associate - Contract

Key Responsibilities

• Lead site start-up activities for post-market observational studies, registries, and related real-world evidence initiatives.
• Manage site feasibility, qualification, readiness assessment, and activation workflows.
• Coordinate collection, review, tracking, and follow-up of essential regulatory and start-up documents.
• Support negotiation and execution tracking for Clinical Trial Agreements, Statements of Work, budgets, purchase orders, and related site documentation.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Pharmacovigilance, and external vendors to support timely site activation.
• Serve as primary operational contact for assigned clinical sites throughout study conduct.
• Conduct remote and on-site monitoring visits, including initiation, routine monitoring, and closeout visits.
• Perform risk-based monitoring activities to support protocol compliance, subject safety, data quality, and regulatory compliance.
• Review study data for completeness, consistency, and source-document alignment, as applicable to the study design.
• Issue, track, and facilitate resolution of site queries in collaboration with Data Management and study teams.
• Maintain accurate, complete, and inspection-ready monitoring documentation and site correspondence.
• Support Trial Master File (TMF) quality, completeness, and essential document maintenance throughout the study lifecycle.
• Document monitoring findings, action items, follow-up, and issue resolution in a timely and traceable manner.
• Contribute to audit and inspection readiness activities.
• Support development and revision of study tools, training materials, monitoring plans, site-facing handouts, and operational procedures.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Public Health, Clinical Research, or a related field.
• Minimum 3 years of CRA, Clinical Research Coordinator, or Clinical Operations experience.
• Experience with site start-up, site activation, and site management activities.
• Experience conducting monitoring visits, either remotely or on-site.
• Working knowledge of GCP, ISO 14155, applicable FDA regulations, and clinical research documentation standards.
• Experience using EDC systems, remote monitoring tools, and clinical trial document repositories.
• Strong communication, organization, follow-up, and project management skills.
• Ability to travel approximately 25–40%, based on study and site needs.