Clinical Research Associate - France

Overview:

On behalf of our client, a pharma-biotech company developing innovative oncology medicines, we are seeking a Clinical Research Associate.

Description

The Clinical Research Associate (CRA) conducts clinical monitoring tasks at trial sites, ensuring adherence to ICH guidelines, GCP, local regulations, and SOPs. Depending on experience and project requirements, responsibilities may involve CRA or start-up duties.

Key duties encompass overseeing oncology/hematology trials within the designated area, including site selection, initiation, conduct, and timely completion. Identifying improvement areas and proposing Corrective And Preventive Actions (CAPA) are integral to the role.

The CRA supports start-up operations and offers local expertise, collaborating closely with the Regional Clinical Operations Manager to maintain study timelines and quality standards.

CRA Tasks

• Conduct feasibility assessments, site identification, and evaluation, including initial site lists and recruitment targets.
• Deliver protocol and study-related training to designated sites.
• Perform monitoring visits (pre-study, initiation, routine, closeout) as per monitoring plan and SOPs.
• Conduct co-monitoring visits if necessary.
• Prepare monitoring visit reports aligned with ICH-GCP and Corporate standards.
• Manage site performance by monitoring regulatory submissions, recruitment, CRF completion, and data query resolution.
• Maintain regular communication with sites, reporting progress, issues, and proposed actions to Clinical Operations.
• Ensure study and site inspection readiness.
• Collaborate with the Regional Clinical Operations Manager and study sites to achieve study milestones.
• Attend disease-specific and general CRA training sessions.
• Facilitate Study Oversight Visits (SOVs), audits, or inspections as needed.
• Evaluate site practices for quality and integrity, escalating issues as appropriate.
• Proactively anticipate and address site issues, suggesting corrective and preventive actions, while striving for operational excellence and promoting innovation.

Qualifications:

• Thorough understanding of clinical trial processes, ICH guidelines, and associated regulatory guidelines.
• Ideally 2-4 years of CRA experience in the pharmaceutical or CRO industry.
• Strong communication and interpersonal skills.
• Excellent organizational abilities, prioritization, and multitasking.
• Fluency in English and French (both written and spoken).

Computer Skills: Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

Travel requirement: up to 60%.

Contact :

Gilles COUTARD – HealthTech Executive Recruitment - ANTAL International – https://www.linkedin.com/in/gilles-coutard/ Haut du formulaire

Ref CJR-20240206-CRA-GC

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