Precision for Medicine is looking to solve the problem of conducting clinical studies in oncology, specifically in the area of precision medicine, by hiring a Clinical Research Associate II/Senior Clinical Research Associate to monitor and own the progress of clinical studies at investigative sites.
Requirements
- 2 (two) 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
- Oncology experience
- Fluency in English and for non-English speaking countries the local language of country where position based
- Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment
- Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline (preferred)
- Knowledge of ICH-GCP and applicable regulations and standards
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 (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)
- 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 site visits and ensure compliance with protocols and regulations
Other
- 4-year college degree or equivalent experience
- Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment
- Residence in Madrid or Barcelona
- Ability to work in a team and communicate effectively
- Adaptability and flexibility in a fast-paced environment