CRA/Senior CRA - Home-Based in Germany
- Experience Level
- Experienced (non-manager)
Home-Based Senior CRA – Germany – US-Based CRO – Oncology and Rare Disease Projects
Upsilon Global are working closely with a US-Based CRO, who are currently expanding their Clinical presence across Europe and so are looking for a Senior CRA in Germany in fully home-based positions.
They are operational in a wide range of countries across Europe including the UK, Germany, The Netherlands and Italy and are looking to cement their clinical operations within Germany.
This expanding CRO conduct studies in early phase Oncology projects with exciting and niche American and Swiss biotech sponsors, offering you the opportunity to work on the full cycle of a clinical trial from regulatory submissions and site feasibility, through to study close-out and database lock. This allows each and every CRA to develop their skills much further than a CRA in a larger CRO, setting you up for Project Management in the future!
Details confidential, information available upon request. Specialist mid-sized CRO establishing a presence in Germany and seeking people looking to join them on their development journey. You will be a crucial member of this growing department and the progression opportunities and endless.
- Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.
- To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
- Ensure that all study related communication including e-mail is tracked, printed and filed as required
- The set-up and coordination of Phase I-IV clinical trials across Germany
- To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
- To liaise with all other appropriate departments to ensure the smooth running of the study
- Mentor and train other CRA’s as and when required
- Perform document submissions to local authorities
- To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
- Other Ad-Hoc CRA duties
Education and Qualifications
- A BSc or BA degree in a lifescience related field
- Minimum of 5 years independent monitoring experience within Germany
- Sound knowledge of ICH/GCP and regulatory requirements
- Experience using clinical trial management systems
Other skills and abilities
- The ability to communicate effectively in English and German
- Good computer literacy with working knowledge of PCs, Windows and Microsoft Office
- Full capabilities to drive in Germany
- Regulatory experience strongly desired
Salary and Benefits
- Competitive salary
- Home-based role
- Great opportunities for career progression
- Fantastic company culture and cross-functioning teams and departments
For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0). 20. 3. 87. 5. 99. 66. or email ‘applications (at) upsilonglobal . com’
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