Precision for Medicine, Oncology and Rare Disease is looking to solve the problem of conducting clinical studies in accordance with protocols, SOPs, ICH-GCP, and all applicable regulations and standards.
Requirements
- experience in oncology
- 1,5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies
- site management or equivalent experience in clinical research
- study start up activities experience (preferred)
- fluency in English and for non-English speaking countries the local language of country where position based
- experience with ICH-GCP and applicable regulations and standards
- knowledge of clinical research principles and practices
Responsibilities
- monitor and own the progress of clinical studies at investigative sites
- ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
- coordinate all necessary activities required to set up and monitor a study
- identify potential study risks and propose solutions on how to mitigate them
- take responsibility in the quality and outcomes of your work
- handle conflict by using tried and true resolution strategies
- conduct pre-study and initiation visits
Other
- graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
- excellent communication and organizational skills are essential
- availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment
- client focused approach
- team player with ability to work in a team environment
