CRA II/Senior CRA - Germany

A large pharmaceutical company is currently recruiting for a CRA II/Senior CRA position with their Germany office, with national travel. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.

Job Responsibilities

• Monitoring assigned clinical trials and ensuring investigators are conducting the clinical study within requirements of the clinical protocol and applicable regulations.
• Serving as the primary contact with the investigators.
• Coordinating all correspondences with clinical sites.
• Conducting periodic site file audits to ensure compliance with GCPs and company standard operating procedures.
• Writing monitoring reports after each monitoring visit on time.
• Regularly communicating with clinical sites and ensuring documents in Trial Master File are up to date.
• Participating in the clinical site recruitment process. Performing site initiation and close-out activities.
• Preparation of study initiation documents.
• Working with clinical site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Maintaining an effective interface with the company's commercial operations to ensure the interface with clinical study sites is managed professionally and is well-coordinated to build goodwill and business value.
• Working closely with the Clinical Data Manager to ensure data captured, collected and queried appropriately within agreed specifications.
• Preparation for Clinical Events adjudication committee meetings.
• Assisting in writing Clinical Study Reports.
• Regularly reviewing Clinical and Regulatory documentation.
• Assisting in setting up and addressing any issues with clinical study agreements.

Skills and Requirements

• A Bachelor's degree in a scientific or health-related field is required.
• Formal training in ICH-GCP regulations.
• Knowledge of GDPR.
• At least 2 years of clinical study experience, ideally in medical devices.
• Advanced understanding of GCPs and ICH; European and international (OUS) clinical trial regulations and guidelines.
• EDC system experience preferred.
• Experience in auditing, ICH GCP and EU MDR.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Fully proficient in the use of MS Word, Excel, PowerPoint and clinical data management systems.
• Fluent in German and English.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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