Clinical Research Associate

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

📋 Description

• Act as the primary CTI representative for designated study sites

• Execute pre-study assessments, site initiation, interim monitoring, and close-out visits

• Fulfill site visit responsibilities with high quality and in accordance with Monitoring Plan schedules

• Aid in or supervise study start-up, feasibility studies, pre-study tasks, and site selection processes

• Gather, evaluate, and monitor essential and regulatory documentation

• Engage in necessary general and study-specific training sessions

• Take part in investigator, client, and project team meetings, including delivering presentations when required

• Develop and implement strategies for subject enrollment

• Ensure the correct storage, distribution, and accountability of investigational products and trial-related materials

• Provide continuous updates on site status to the Clinical Project Manager

• Carry out remote monitoring as per the study-specific Monitoring Plan

• Monitor subject status, CRF retrieval, source document examination, regulatory documents, and investigational products using various systems and reports

• Support 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 standards

• Proficient in spoken and written English at a minimum of Level B2

• Capability to conduct pre-study assessments, site initiation, interim monitoring, and close-out visits

• Proficient in site management and remote monitoring tasks

• Ability to oversee investigational products and trial-related materials

• Competence in collecting, reviewing, and monitoring essential and regulatory documents

🏝️ Benefits

• Structured mentoring program

• Leadership development courses

• Dedicated training department

• Ongoing education support

• Hybrid work opportunities

• CTI Cares community and charitable involvement opportunities

• Opportunity to contribute to life-changing treatments for patients with chronic and critical illnesses