CRA II, Oncology

This is a fully remote position, open to applicants in France.

📋 Description

• Conduct site qualification, site initiation, interim monitoring, site management, and close-out visits either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol compliance.

• Assess the performance of the site and its staff, providing recommendations for site-specific actions.

• Identify serious issues and formulate action plans for resolution.

• Verify informed consent processes, maintain subject confidentiality, and ensure safety and clinical data integrity.

• Evaluate site processes and perform source document reviews.

• Confirm the accuracy and completeness of clinical data in case report forms.

• Resolve queries both remotely and on-site within established timelines.

• Assist in the review of clinical study data, capturing compliance for electronic data capture.

• Oversee the inventory, reconciliation, storage, dispensing, and administration of investigational products as necessary.

• Review Investigator Site Files and align them with the Trial Master File.

• Document monitoring activities using required project documentation and tracking systems.

• Support recruitment, retention, and awareness strategies for subjects/patients.

• Manage site-level activities, communications, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring site-team training and compliance.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Assist in audit readiness, preparation, and follow-up actions.

• For Real World Late Phase, provide support to sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff when requested, identify out-of-scope activities, and propose potential sites.

⛳️ Requirements

• A Bachelor’s degree or RN in a related field, or an equivalent mix of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Ability to manage travel requirements of up to 75% on a regular basis.

• Working knowledge of applicable regulations and company SOPs/processes.

• For Real World Late Phase: understanding of local requirements for real-world late phase study designs.

• Must complete assigned training as necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• An inclusive company culture.

• Reasonable accommodations provided when appropriate.