Associate Clinical Trial Manager (PhD)
Les Patients au coeur de la Recherche Clinique · Le Mars, IA · 3 days ago
AnalystFull-time
About the role
We are seeking a Clinical Research Associate to join our team.
Responsibilities
- Monitor clinical trial sites to ensure compliance with protocols, GCP, and applicable regulations
- Conduct site selection, initiation, monitoring, and close-out visits
- Verify data accuracy and integrity through source document verification
- Manage study documentation and ensure proper filing and archiving
- Communicate with investigators and site staff to resolve study-related issues
- Support the development of study protocols and case report forms
- Prepare and submit regulatory documents as required
Requirements
- Bachelor's degree in life sciences, nursing, or related field
- Minimum 2 years of clinical monitoring experience in a CRO or pharmaceutical company
- Thorough knowledge of ICH-GCP guidelines and EU clinical trial regulations
- Strong understanding of clinical research processes and documentation
- Excellent communication and problem-solving skills
- Proficiency in Microsoft Office and CTMS systems
- Valid driver's license and willingness to travel up to 60%
Qualifications
- Certification as a CRA (e.g., ACRP or SOCRA) preferred
- Experience in oncology, cardiology, or rare diseases is a plus
- Fluency in French and English, both written and spoken