Senior CRA, Oncology

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

📋 Description

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

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site personnel, providing recommendations and action plans.

• Verify informed consent protocols, maintain subject/patient confidentiality, and ensure safety and integrity of clinical data.

• Perform reviews of source documents and validate clinical data within case report forms.

• Resolve queries both remotely and on-site while guiding site staff.

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

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities and maintain tracking systems effectively.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Oversee site-level operations, communications, deliverables, and timelines.

• Coordinate with project site personnel to ensure proper training and compliance of the site team.

• Prepare for and participate in investigator and sponsor meetings.

• Engage in or lead clinical monitoring/project staff meetings when relevant.

• Aid in maintaining audit readiness and follow-up actions.

• Provide training or mentorship to junior Clinical Research Associates (CRAs).

• For RWLP studies, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsors and local teams, identify sites, develop country-level informed consent forms, assist with regulatory updates, and participate in bid defense meetings.

⛳️ Requirements

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

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

• Proficient computer skills with an openness to adopting new technologies.

• Strong communication, presentation, and interpersonal skills.

• Basic critical thinking abilities.

• Willingness to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations available when necessary.