We are looking for an experienced Clinical Research Associate (CRA) /Lead CRA for our CRA team at Eurofins bioskin in Hamburg. The senior CRA will manage all aspects of clinical monitoring to ensure quality compliance and oversight to applicable regulations.
Focus of tasks:
- Coordinate team of CRAs
- CoMonitoring training and support of junior or freelance CRA team (inhouse and freelance CRAs)
- Act as a CRA and Lead CRA for defined project(s) i.e. performing onsite monitoring (including site selection initiation periodic and close out visits) as well as remote monitoring and riskbased monitoring for clinical trials phase IIII
- Close cooperation with internal interface departments and external stakeholders
- Giving input to financial proposals for monitoring activities
- Represents bioskin in bid defenses and investigator meetings
- Identify and implement possible improvements to current processes determine new processes that are needed
Qualifications :
Profile:
- Degree in a scientific or medical discipline
- 5 years of industry experience working on clinical trials/investigations and at least 2 years of experience as CRA in leading position are imperative ideally including multicenter and multinational trials
- Open to travel including overnight stays
- Advanced knowledge of and ability to apply GCP/ICH ISO 14155 and all applicable regulatory guidelines
- Fluent in German and English (written and spoken)
- Wellstructured and organized targetoriented personality must work both independently and in a team environment
- Capability to communicate complex issues clearly
- Candidates with experiences in the indication dermatology will be preferred
- Home office based work is possible (at least partially officebased work in Hamburg preferred)
Additional Information :
Contacts by headhunters recruiting or staffing agencies are not accepted!
Please send your complete application including your anticipated salary to:
Bitte senden Sie Ihre vollstndige EMailBewerbung als PDFDatei mit Gehaltsvorstellung an:
bioskin GmbH Messberg 4 20095 Hamburg Bettina Mhlenbrock Email:
Please send applications by email as pdf file.
Remote Work :
No
Employment Type :
Fulltime