Clinical Research Associate
J
JobgetherPharmaceutical / Biotech
FranceFull-TimeMiddle
Salary43,000 - 53,700 EUR per year
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Job Details
- Languages
- Fluency in both French and English, written and spoken.
- Experience
- Minimum of 2 years of Clinical Research Associate monitoring experience
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Bachelor's degree in a scientific discipline or a related field.
- Minimum of 2 years of Clinical Research Associate monitoring experience within the pharmaceutical, biotechnology, or CRO industry.
- Solid understanding of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements.
- Fluency in both French and English, written and spoken.
- Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Outlook, and project management applications.
- Ability to travel up to 60% within the assigned region.
- Strong analytical mindset with the ability to identify issues and assess risks.
- Excellent organizational skills with the ability to manage multiple priorities.
- Oncology and/or hematology clinical trial experience (preferred).
- Study start-up activities experience (advantage).
Responsibilities
- Conduct site feasibility assessments, identification, selection, and evaluation activities.
- Perform monitoring activities including pre-study, site initiation, routine monitoring, co-monitoring, and closeout visits.
- Deliver protocol and study-related training to investigative sites.
- Track site performance metrics, including regulatory submissions, patient recruitment, CRF completion, and query resolution.
- Ensure inspection readiness by maintaining documentation and supporting audits and regulatory inspections.
- Identify risks, quality concerns, and operational gaps, proposing corrective and preventive actions (CAPAs).
- Collaborate with Clinical Operations teams and site personnel to drive study progress.
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