CRA II/Senior CRA - Home based - Germany
A large medical technology and device company is currently recruiting for a CRA II/Senior CRA position with their Germany office on a home-based capacity. 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.
Regulatory / Quality 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani on 0203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.