Senior Clinical Research Associate, GICORS
PPD - Pharmaceutical Product Development
The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and Sponsor’s SOPs. The CRA conducts site visits to assess protocol and regulatory compliance and manages required documentation, and ensures that data will pass international quality assurance audits. The CRA also develops collaborative relationships with investigational sites.
Education and Experience:
- Medical, pharmaceutical or other life-science related degree;
- Ideally 3 to 4 years of Clinical Research experience, as well as minimum 2 years monitoring experience in a CRO, pharmaceutical or biotech company.
- Demonstrated clinical trial monitoring skills;
- In-depth understanding of ICH/GCP guidelines;
- Excellent standard of verbal and written communication skills in English;
- Highly organized with strong attention to detail and deadlines;
- Advanced skills across all of the Microsoft packages;
- Willingness to travel.