Clinical Trial Associate

PathAI; Salem (OR); Presencial; USD 65 000 - 85 000; Tempo integral

Resumo da oferta

PathAI in Salem, OR is seeking a Clinical Trial Associate to support clinical operations and lab services monitoring across sponsored studies. You will coordinate with investigator sites, manage trial queries, and assist with data integrity and regulatory compliance throughout study execution.

The role requires strong knowledge of GCP/ICH and experience with trial management platforms, plus excellent organization and communication for cross-functional teams.

Qualificações

• Strong knowledge of GCP, ICH guidelines, and 21 CFR regulatory requirements.
• Knowledge of clinical trial operations and good clinical practices.
• Experience monitoring investigator sites or clinical trial performance metrics.
• Proficiency with clinical trial management platforms and data systems.
• Excellent organizational and communication skills for cross-functional coordination.
• Ability to manage multiple studies concurrently.

Responsabilidades

• Monitor clinical trial lab services, specimen management, and investigator site performance.
• Oversee query closure and resolve data discrepancies.
• Support Clinical Trial Manager with routine administrative tasks.
• Coordinate with laboratories, vendors, and sponsors on kit distribution and result delivery.
• Maintain project documentation and assist with study startup and closeout procedures.

Conhecimentos

GCP understanding

ICH guidelines

21 CFR regulatory

Cross-functional coordination

Organizational skills

Communication skills

Multi-study management

Ferramentas

Clinical trial management platforms

Data systems

Descrição da oferta de emprego

PathAI seeks a Clinical Trial Associate to support clinical operations and lab services monitoring across sponsored studies. The role involves coordinating with investigator sites, managing trial queries and data discrepancies, and ensuring regulatory compliance throughout study execution.

Responsibilities

• Monitor clinical trial lab services, specimen management, and investigator site performance
• Oversee query closure and collaborate on resolution of data discrepancies
• Support Clinical Trial Manager with routine administrative tasks and backup coverage
• Coordinate with laboratory, vendors, and sponsors on kit distribution and result delivery
• Maintain project documentation and assist with study startup and closeout procedures

Requirements

• Strong understanding of GCP, ICH guidelines, and 21 CFR regulatory requirements
• Knowledge of clinical trial operations and good clinical practices
• Experience monitoring investigator sites or clinical trial performance metrics
• Proficiency with clinical trial management platforms and data systems
• Excellent organizational and communication skills for cross-functional coordination
• Ability to manage multiple studies and escalat ...