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WEP Clinical · 7 hours ago

Senior Clinical Research Associate (France)

United States

Full-time

Remote

Senior Level

5+ years exp

WEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Senior Clinical Research Associate (Senior CRA) plays a crucial role in overseeing clinical monitoring and site management, ensuring compliance with regulatory requirements and maintaining essential documentation. This position involves building strong relationships with sponsors and sites, conducting monitoring visits, and supporting the development of study-specific procedures.

BiotechnologyInformation TechnologyPharmaceutical

Responsibilities

Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans)

Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection

Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements

Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations

Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready

Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions

Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence

Track and close action items within study or company timelines; maintain clear oversight of monitoring deliverables

Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates

(Lead CRA, if assigned) Oversee monitoring on complex studies; develop study-specific monitoring documents (e.g., CMP, deviation plan, report templates); finalize visit reports; train/coordinate CRAs; act as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations

Qualification

Clinical monitoringGCP complianceSite managementClinical research experienceMS Office proficiencyCommunicationProblem solvingDetail orientedAdaptability

Required

Leader

Detail Oriented

Problem Solver

Adaptable