Job Summary
The Clinical Research Associate II is vital in overseeing and managing clinical trials, ensuring adherence to regulatory guidelines and protocols. This role demands a keen focus on maintaining data integrity and patient safety while facilitating communication between stakeholders throughout the study lifecycle.
Responsibilities
- Monitor clinical trial sites to ensure compliance with study protocols and regulatory requirements.
- Conduct regular site visits for the assessment of study progress and issue resolution.
- Manage and verify the accuracy of clinical data collected from sites.
- Facilitate effective communication between the project team, investigators, and regulatory bodies.
- Assist in the development and maintenance of study documentation and reports.
Qualifications
- Bachelor’s degree in life sciences or a related field.
- Proven experience as a Clinical Research Associate, preferably with a focus on Phase II and III trials.
- Strong knowledge of Good Clinical Practice (GCP) and other applicable regulations.
- Excellent communication skills, both written and verbal, with the ability to collaborate effectively.
- Proficiency in data management systems and Microsoft Office applications.
