The main task of the CRA is to act as a link between sponsor CRO and trial site as well as to perform quality control of clinical trials. The focus is on clinical studies conducted in-house at bioskin or in the Northern German region.
Your main responsibilities:
- Perform all kind of the monitoring visits (site selection initiation periodic and close-out visits) as well as remote monitoring
- Generation and updating of monitoring plans and site initiation presentation
- Evaluating the quality and integrity of site practices
- Act as contact for clinical trial suppliers and other vendors as assigned
- Identifying and escalating protocol deviations discrepancies in data and non-compliance to clinical trial protocols
- Close cooperation with the different departments in-house at bioskin as well as freelance CRAs
- Compliance with protocol GCP/ICH Guidelines
Qualifications :
The ideal Candidate will need the following experience to be considered:
- Min. 2 years of the clinical monitoring experience (preferred Dermatology)
- Degree in a scientific or medical discipline or equivalent
- Very good knowledge of Good Clinical Practice/ICH Guidelines
- Proven ability to work independently in a fast-paced environment
- Excellent communication interpersonal and organizational skills
- Fluency in German and a high level of English language
- located in Hamburg
Additional Information :
Contacts by headhunters recruiting or staffing agencies are not accepted!
Remote Work :
Yes
Employment Type :
Full-time