Moniteur Médical
Les Patients au coeur de la Recherche Clinique · Le Mars, IA · 4 days ago
OTHRFull-time
About the role
AFCROs is seeking a Clinical Research Associate (CRA) to join our team.
Responsibilities
- Monitor clinical trial sites to ensure compliance with protocols, ICH-GCP, and applicable regulations
- Conduct site selection, initiation, monitoring, and close-out visits
- Verify data accuracy and source documentation at investigative sites
- Manage study drug accountability and ensure proper storage and dispensing
- Prepare and maintain monitoring visit reports and study documentation
- Coordinate with study team members and site personnel to resolve queries
- Ensure timely collection and reporting of adverse events and serious adverse events
Requirements
- Bachelor's degree in life sciences, pharmacy, nursing, or related field
- Minimum 2 years of experience as a CRA in a CRO or pharmaceutical company
- Thorough knowledge of ICH-GCP guidelines and European clinical trial regulations
- Experience with electronic data capture systems and CTMS
- Excellent communication and interpersonal skills
- Ability to travel up to 60% of working time
- Fluency in English and French
Qualifications
- Certification as a Clinical Research Associate (CCRA) preferred
- Experience in oncology or medical device trials is an advantage
- Familiarity with French regulatory environment (CPP, ANSM) is a plus
Skills
- Strong attention to detail and organizational skills
- Ability to work independently and manage multiple priorities
- Problem-solving mindset and proactive approach
- Proficiency in Microsoft Office applications