Clinical Research Associate II – Senior Clinical Research

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

📋 Description

• Act as the main Clinical Trial Investigator (CTI) liaison for designated study sites.

• Carry out site visits including pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV), ensuring that all deliverables are completed to a high standard and within the timelines set out in the Monitoring Plan, while complying with all relevant regulatory requirements, SOPs, and ICH-GCP guidelines.

• Assist with or manage study start-up tasks, such as feasibility evaluations, pre-study activities, and site selection.

• Gather, examine, and maintain essential and regulatory documentation.

• Engage in and fulfill all mandatory general and study-specific training.

• Participate in investigator, client, and project team meetings, which may include delivering presentations.

• Create and execute subject enrollment strategies for the assigned study sites.

• Ensure the proper storage, dispensing, and tracking of all Investigational Product (IP) and trial-related materials.

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

• Conduct remote monitoring and complete associated tasks as specified in the study-specific Monitoring Plan.

• Utilize systems and reports to monitor subject status, CRF retrieval/source document verification (SDV), regulatory documents, and IP.

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

⛳️ Requirements

• 3–5 years of clinical research experience as a Clinical Research Associate (CRA) or in a related capacity in Germany, including independent monitoring experience within the country.

• A degree or background in life sciences.

• In-depth knowledge of ICH-GCP and regulatory standards.

• Proficient in both German and English (spoken and written), with a minimum CEFR level of B2.

🏝️ Benefits

• Health insurance.

• Opportunities for professional development.

• Hybrid work options.