Clinical Research Associate – Level Dependent on Experience

This is a fully remote position, open to applicants in France.

📋 Description

• Act as the primary CTI liaison for designated study sites.

• Execute pre-study assessments, site initiation, interim monitoring, and final visits.

• Fulfill site visit obligations with excellence and in accordance with Monitoring Plan schedules.

• Comply with relevant regulatory standards, SOPs, and ICH GCP guidelines.

• Support or manage study start-up tasks, including feasibility assessments, pre-study initiatives, and site selection.

• Gather, evaluate, and monitor essential and regulatory documentation.

• Complete both general and study-specific training programs.

• Engage in investigator, client, and project team discussions, including delivering presentations.

• Develop and execute strategies for subject enrollment.

• Ensure appropriate storage, distribution, and accountability of Investigational Products and trial-related materials.

• Conduct site management tasks and provide continuous updates on site status to the Clinical Project Manager.

• Implement remote monitoring as per the study-specific Monitoring Plan.

• Monitor subject status, retrieve CRFs, review source documents, and track regulatory documents and Investigational Products using various systems and reports.

• Contribute to project-specific tasks as a member of the Project Team.

⛳️ Requirements

• 3–5 years of experience in clinical research as a CRA or in a related field.

• Experience in independent monitoring within Germany.

• Background in life sciences.

• Strong understanding of ICH-GCP and regulatory guidelines.

• Proficient in spoken and written English, with at least a Level B2 proficiency.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing education support.

• Hybrid work options.

• CTI Cares community and global giving initiatives.

• Opportunity to work on life-changing treatments for patients with chronic and critical illnesses.