[Hiring] CRA II @Worldwide Clinical Trials

Role Description

As a CRA II, you’ll play a critical role in ensuring the quality, integrity, and success of clinical research studies. Your work will directly support patient safety and high-quality data collection, helping advance important research from site activation through study close-out.

• Conduct site qualification, initiation, monitoring, and close-out visits in compliance with study protocols and regulatory requirements.
• Evaluate site feasibility and support site selection activities for new and ongoing studies.
• Review source documentation and study data to ensure accuracy, patient safety, protocol compliance, and data integrity.
• Prepare, maintain, and verify regulatory and ethics documentation required for study conduct.
• Train and support site personnel on protocol requirements, study processes, and GCP standards.
• Partner with investigative sites to resolve data queries, maintain study documentation, and support audit readiness.
• Monitor investigational product accountability, including receipt, storage, return, or destruction activities.
• Document site visit findings and provide timely updates and essential documentation for Trial Master File maintenance.
• Collaborate with study teams and support the development of monitoring-related study materials and processes as requested.

Qualifications

• Medical Doctor (MD) degree, Pharmacy degree, or equivalent life science qualification with the required clinical research experience; or a four-year degree in a medical, biological, physical, health, pharmacy, or related scientific discipline with clinical research experience.
• Minimum experience requirements consistent with a CRA II level role, including prior experience in clinical research and site monitoring activities.
• Thorough understanding of clinical research processes, GCP, ICH guidelines, FDA and/or EU regulations, and local regulatory requirements.
• Experience managing investigative sites through study start-up, monitoring, and close-out activities.
• Knowledge of multiple therapeutic areas and the ability to independently support clinical trial execution.
• Proficiency with Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms.
• Experience in full-service monitoring PREFERRED.
• Fluent in German and proficient in spoken and written English; valid passport, driving license, and willingness to travel required.

Company Description

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.