- Company Name
- WEP Clinical
- Job Title
- Senior Clinical Research Associate - (France)
- Job Description
-
Job title: Senior Clinical Research Associate
Role Summary:
Lead clinical monitoring and site management for complex studies, ensuring compliance with ICH‑GCP, regulatory guidelines, and internal SOPs. Serve as primary contact for sponsors, investigators, and regulatory bodies while training and supervising other CRAs.
Expected Experience:
5–7+ years of onsite/remote monitoring or equivalent clinical research experience; senior CRA level II (5+ years) with proven ability to handle complex sites, mentor peers, and drive process improvement.
Key Responsibilities:
• Design and review study documents (protocols, CRFs, ICFs, monitoring plans).
• Lead site feasibility: distribute questionnaires, conduct SQVs, recommend sites.
• Plan and execute SIVs, routine monitoring, and close‑out visits per protocol and ICH‑GCP.
• Build relationships with site staff; provide training, guidance, and resolve regulatory issues.
• Verify source data and CRFs, ensure audit‑ready documentation.
• Review IP accountability, safety events, and deviations; initiate CAPAs.
• Manage and resolve data queries, analyze error trends, retrain as needed.
• Track and close action items; maintain monitoring deliverables and timelines.
• Support investigator/PM meetings, contribute to SOPs, tools, and templates.
• Oversee monitoring on complex studies; develop study‑specific monitoring documents; train/co‑ordinate CRAs; act as main clinical monitoring point of contact with sponsors; handle escalations.
Required Skills:
• Strong scientific and technical mindset; quick grasp of clinical protocols.
• Excellent organizational, logistical, and time‑management skills.
• Superior written and verbal communication; stakeholder engagement.
• Knowledge of therapeutic areas, medical terminology, and regulatory requirements.
• Proven training, coaching, and mentoring abilities.
• Proficiency in MS Office and EDC systems; willingness to travel up to 80 %.
Required Education & Certifications:
• Bachelor’s degree in life sciences, nursing, or related field.
• GCP knowledge and understanding of ICH, FDA, MHRA, EMA regulations.
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