Clinical Research Associate - Client-dedicated : Vaccines at PPD

Job Profile

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. They also develop collaborative relationships with investigational sites.

Job Qualification
Education And Experience

• Medical, pharmaceutical or other life-science related degree
• At least 1 year of independent monitoring experience in a CRO, pharmaceutical or biotech company

Additional Requirements

• 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 in South Africa and Africa