Job Overview :
Unblinded Clinical Research Associate (uCRA) - sponsor-dedicated
Location : Munich, Germany / Home Office, Germany
A formula for clinical innovation : Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas.
In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications.
If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, joining our growing team of Unblinded CRAs provides you with just these opportunities.
What we have to offer : a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.
As uCRA, you typically will :
Own all aspects of pharmaceutical site management as described in the project plans
Ensure accurate pharmacy documentation
Maintain investigational medicinal product (IMP) accountability
Ensure blinded and unblinded site staff members can work in a coordinated manner without compromising the blinded monitors
Oversee that IMP supplies are maintained in suitable storage conditions and are accurately reconstituted, dispensed, administered, returned and destroyed
Review Case Report Forms (CRF), generate queries and resolve issues in accordance with established data review guidelines on Labcorp or client data management systems
Education / Qualifications :
Degree in a relevant field such as life sciences, biology, pharmacology, (veterinarian) medicine, oecotrophology etc.
In lieu of the above, an equivalent completed vocational education, e.g. as study nurse, or equivalent work experience (study coordinator etc.) in clinical research
Experience in clinical research
First monitoring experience in a comparable function (uCRA or CRA) in Germany, including familiarity with applicable German regulations and authorities
Awareness of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
Working knowledge of Microsoft Word, Excel and PowerPoint
Effective time management and organizational skills and a keen attention to detail
Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
Business fluency in German - both spoken and written - as well as a good command of English are a must