Clinical Research Associate (CRA)

1MED SA; Caen; Sur place; EUR 42 000 - 65 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

ICH-GCP familiarity

ISO 14155 familiarity

Multitasking

English proficiency

Regulatory compliance

Site monitoring

Communication with investigators

Formation

Bachelor's degree or higher in Life Sciences or related

Outils

EDC/eCRF platforms

eTMF systems

MS Office

Description du poste

The Clinical Research Associate (CRA) is responsible for ensuring that clinical studies are conducted in compliance with applicable regulations, ICH-GCP and ISO 14155 guidelines, study protocols, sponsor requirements, and company procedures. Acting as the primary point of contact for assigned investigational sites, the CRA supports studies throughout their lifecycle, from site qualification and initiation through monitoring and study closeout, while contributing to data quality, regulatory compliance, and patient safety.

Key Responsibilities

Site Monitoring & Site Management

• Conduct Site Qualification/Selection Visits (SQV/SEV).
• Perform Site Initiation Visits (SIV).
• Conduct Interim Monitoring Visits (MOV), both on-site and remotely.
• Perform Site Close-Out Visits (COV).
• Prepare monitoring reports, follow-up letters, and related study documentation.
• Ensure ongoing maintenance of the Investigator Site File (ISF), keeping all documentation current throughout the study.
• Ensure timely follow-up of site action items and identified issues.
• Evaluate site performance and proactively identify areas requiring additional support.

Clinical Study Oversight

• Ensure studies are conducted in accordance with study protocols, ICH-GCP, ISO 14155, applicable regulations, sponsor requirements, and company SOPs.
• Verify informed consent processes and documentation.
• Perform Source Data Verification (SDV) and Source Document Review (SDR).
• Review medical records and study documentation.
• Verify the accuracy, completeness, and consistency of CRF/eCRF data.
• Identify, document, and follow up protocol deviations and corrective actions.
• Escalate quality, compliance, or patient safety concerns when appropriate.

Patient Safety & Data Integrity

• Verify that Adverse Events (AEs), Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs), Device Deficiencies, and Concomitant Medications are properly documented and reported.
• Contribute to maintaining patient safety and data integrity throughout the study.

Investigational Product & Device Accountability

• Verify appropriate storage, handling, accountability, reconciliation, and disposition of Investigational Medicinal Products (IMP), Medical Devices, and study supplies.
• Ensure compliance with sponsor and regulatory requirements regarding product accountability.

Site Support & Training

• Act as the primary contact for Investigators and site personnel.
• Provide study-specific and GCP-related training as required.
• Support subject recruitment, retention, and site engagement initiatives where applicable.
• Collaborate closely with Project Managers, Sponsors, and other cross‑functional teams.

Documentation & Quality Management

• Maintain and review Investigator Site Files (ISF).
• Support reconciliation activities between site documentation and the Trial Master File (TMF/eTMF).
• Contribute to audit and inspection readiness.
• Ensure timely and accurate completion of all required study documentation.

Requirements

• Bachelor's Degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or a related scientific discipline.
• Minimum 2 years' experience as a CRA, with demonstrated experience conducting independent site monitoring visits.
• Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations.
• Experience working within a CRO environment is considered an advantage.

Key Skills

• Good understanding and/or practical experience of ICH-GCP and/or ISO 14155, with familiarity with EU MDR clinical investigation and PMCF requirements.
• Knowledge of applicable clinical trial regulations and quality standards.
• Ability to manage multiple studies and priorities simultaneously.
• Strong relationship-building skills with investigators and study site staff.
• Commitment to quality, compliance, and patient safety.
• Availability to travel nationally and internationally (approximately 30-60% depending on study and project requirements).
• Professional proficiency in English, with the ability to communicate effectively in an international clinical research environment and produce high‑quality scientific and technical documentation.

Systems & Technology

• Experience working with EDC/eCRF platforms.
• Familiarity with eTMF systems.
• Good knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Comfortable working with remote monitoring and digital collaboration tools