Clinical Research Associate: Remote & Onsite Monitoring

1MED SA; Caen; On-site; EUR 42,000 - 65,000; Full time

Job summary

1MED SA is seeking a Clinical Research Associate (CRA) to ensure clinical studies comply with ICH-GCP, ISO 14155, and sponsor requirements. You will act as the primary contact for investigational sites throughout the study lifecycle, supporting site qualification, initiation, monitoring, and closeout while safeguarding data quality, regulatory compliance, and patient safety.

The role involves site visits, SDV/SDR activities, documentation reviews, and collaboration with project managers and

Qualifications

• Bachelor's Degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or related field.
• Minimum 2 years' CRA experience with independent site monitoring.
• Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations.
• Experience in CRO environments is advantageous.

Responsibilities

• Conduct Site Qualification/Selection Visits (SQV/SEV) and Site Initiation Visits (SIV).
• Perform Interim Monitoring Visits (MOV), on-site and remotely.
• Conduct Site Close-Out Visits (COV) and prepare monitoring reports.
• Maintain Investigator Site File (ISF) and ensure documentation is current.
• Verify informed consent, SDV/SDR, and data accuracy.
• Ensure product accountability for IMP and Medical Devices.
• Provide site training and support recruitment and engagement.
• Collaborate with Project Managers, Sponsors and cross-functional teams.

Skills

ICH-GCP familiarity

ISO 14155 familiarity

Multitasking

English proficiency

Regulatory compliance

Site monitoring

Communication with investigators

Education

Bachelor's degree or higher in Life Sciences or related

Tools

EDC/eCRF platforms

eTMF systems

MS Office

Job description

1MED SA is seeking a Clinical Research Associate (CRA) to ensure clinical studies comply with ICH-GCP, ISO 14155, and sponsor requirements. You will act as the primary contact for investigational sites throughout the study lifecycle, supporting site qualification, initiation, monitoring, and closeout while safeguarding data quality, regulatory compliance, and patient safety.

The role involves site visits, SDV/SDR activities, documentation reviews, and collaboration with project managers and