Precision for Medicine, Oncology and Rare Disease is seeking to hire a Clinical Research Associate II in Poland to manage and monitor clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Requirements
- 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.
- Experience in oncology
- Study start up activities experience
Responsibilities
- You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
- You will 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.).
Other
- You are calm, thoughtful, and responsive when things don’t go as planned.
- You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
- You find quick and creative ways of overcoming difficulties.
- You have an impeccable eye for detail.
- You identify potential study risks and propose solutions on how to mitigate them.
