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 (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Requirements
University degree in life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
At least 6 months of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
Site management experience or equivalent experience in clinical research.
Oncology monitoring experience.
Excellent communication and organizational skills are essential. A team player.
Evidence of a client focused approach.
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.