Clinical Research Associate - Ophthalmology (Freelance, Southern Germany)

Job Overview

We are looking for a skilled Freelance Clinical Research Associate (CRA) to contribute to an ophthalmology clinical trial based in Southern Germany, ideally near Stuttgart or Munich. This opportunity begins as a part-time engagement, approximately 10-20% of full-time effort, with the potential for involvement in additional future clinical research projects within Germany.

Key Responsibilities

• Assist in study start-up procedures for an ophthalmology clinical trial.
• Ensure adherence to German regulatory standards and ethical guidelines throughout the research process.
• Review and modify Informed Consent Forms (ICFs) to meet local German regulatory requirements.
• Collaborate closely with study sites and project teams to facilitate smooth study initiation.
• Maintain compliance with ICH-GCP guidelines, clinical trial protocols, and all applicable local regulations.

Candidate Requirements

• Proven prior experience as a Clinical Research Associate in clinical research settings.
• Demonstrated expertise in ophthalmology clinical trials.
• Strong background in study start-up activities.
• Comprehensive knowledge of German regulatory and ethics processes related to clinical research.
• Experience in adapting and reviewing consent documentation specific to Germany.
• Fluency in both German and English languages.
• Residency in Southern Germany, preferably in the regions of Bavaria or Baden-Württemberg.

Contract Details

• Engagement of 0.1 to 0.2 Full-Time Equivalent (FTE) initially.
• Position offered as a freelance contract.
• Possibility to contribute to additional clinical research initiatives in Germany as they arise.