Clinical Research Associate II

Summary

Join Precision for Medicine, a CRO with high CRA retention rates, offering a unique work environment. As a CRA II, you will be fully remote in Romania, enjoying a lower-than-average protocol workload and reasonable travel. You will monitor clinical studies, ensuring compliance with protocols and regulations. Your responsibilities include coordinating study setup, investigator identification, and regulatory submissions. Precision values employee input and offers opportunities for growth and influence. The company is passionate about rare diseases and oncology, using biomarkers to link mutations to treatments and deliver robust insights.

Requirements

• 4-year college degree or equivalent experience
• Candidates should ideally have at least 2 years CRA experience within the CRO or pharmaceutical industry
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
• Fluency in Romanian and the English language

Responsibilities

• 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
• 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.)

Preferred Qualifications

• Oncology experience, early phase experience desirable although not essential
• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline