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