Clinical Research Associate (Home-based)
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Hobson Prior are currently seeking a Clinical Research Associate to be homebased for an organisation who designs and manufactures surgical instruments. As the CRA you will accountable for monitoring assigned clinical trials and ensure investigators are conducting the clinical study within requirements of the clinical protocol and applicable regulations.
- Represents as the primary contact with the investigators.
- You will coordinate all correspondences with clinical sites and the organisation.
- Conducts periodic site file audits to ensure compliance with GCPs and company standard operating procedures.
- Writing monitoring reports after each monitoring visit on time.
- Regularly communicate with clinical sites and ensure documents in Trial Master File are up to date.
- Partake in the clinical site recruitment process. Perform site initiation and close-out activities.
- Preparation of study initiation documents. Work with clinical site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
- Maintain an effective interface with the commercial operations to ensure the interface with clinical study sites is managed professionally and is well-coordinated to build goodwill and business value.
- Good communication, organisational skills and ability to work in a team is essential.
- Fluent in German and English.
- Excellent English writing skills.
- A Bachelor's degree in a scientific or health-related field is required.
- 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.
- Fully proficient in the use of MS Word, Excel, PowerPoint and clinical data management systems.
- EDC system experience preferable.
- Formal training in ICH-GCP regulations.
- Knowledge of GDPR.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.