PSI CRO AG este o organizație globală de cercetare contractuală care sprijină studiile clinice, cu accent pe studiile esențiale de fază 2 și fază 3. Activitatea sa acoperă domenii terapeutice precum bolile inflamatorii intestinale, oncologia, hematologia, bolile infecțioase, scleroza multiplă și bolile rare. Compania utilizează o platformă proprie pentru planificarea studiilor clinice și monitorizarea financiară, ajutând echipele să urmărească termenele și bugetele studiilor. Profilul PSI CRO AG combină expertiza în domeniul sănătății și consultanței, punând accent pe calitate, compatibilitate și desfășurarea fiabilă a studiilor.
Clinical Research Associate II – Oncology | PSI CRO | Remote, United States
PSI CRO is seeking a Clinical Research Associate II to monitor oncology trials across the United States. The role covers site management, data quality, investigational products, audits, recruitment targets, and regulatory documentation.
Descriere
- Serve as the primary communication link among the project team, sponsor, and clinical site
- Develop and maintain effective working relationships with site personnel
- Plan, conduct, and document site selection, initiation, monitoring, and close-out visits
- Set and track site recruitment goals while meeting study timelines
- Maintain accurate, timely communication about adverse events and protocol or process deviations
- Complete source data verification and manage site-level data queries
- Identify and oversee study risks at assigned sites
- Manage, reconcile, document, and return investigational products and clinical supplies
- Review essential documents and reconcile the Investigator Site File and TMF at site level
- Uphold site-level data integrity, quality, and regulatory compliance
- Prepare sites for audits and address resulting findings
- Participate in site audits and client on-site visits when requested
- Coordinate study documents and supplies across project teams, sites, laboratories, reviewers, and warehouses
- Deliver study-specific training to site investigators
- Contribute to the development of Investigator newsletters
- Support Site Management Associates with study-specific and corporate tracking systems
- Assist with draft regulatory and ethics committee submission packages
- Support site- and country-level collection of IP-RED packages
- Coordinate TMF review and reconciliation across country and site levels
Cerințe
- Degree in Life Sciences or an equivalent combination of education, training, and relevant experience
- Preference for candidates based in the Central or West Coast regions
- At least two years of independent on-site monitoring experience
- Experience conducting Phase I–III monitoring visits
- Mandatory oncology experience
- GI and/or radiopharmaceutical experience is preferred
- Full professional proficiency in English
- Proficiency with Microsoft Office applications
- Strong planning and multitasking skills in a dynamic team setting
- Effective communication, collaboration, and problem-solving abilities
- Willingness to travel up to 75%
- Valid driver’s license where applicable
- Must be authorized to work without requiring a visa now or in the future
Beneficii
- Opportunities to develop clinical research skills further
- Opportunities to expand therapeutic-area experience
- Path to deeper expertise in clinical research
- Remote work arrangement