Job Summary
The Clinical Research Associate II is a vital role in the management and monitoring of clinical trials. This position demands expertise in ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and Good Clinical Practice (GCP). The individual will be responsible for overseeing various aspects of clinical studies, contributing to the advancement of medical research.
Responsibilities
- Monitor clinical trial sites to ensure compliance with regulatory standards and protocols.
- Conduct site initiation, monitoring, and close-out visits.
- Review and verify source documents and case report forms for accuracy and completeness.
- Maintain regular communication with study sites and project teams to address issues and provide support.
- Assist in the preparation of study-related documents, including protocols and reports.
- Participate in training and mentoring of junior staff or new team members.
Qualifications
- Bachelor’s degree in a relevant field, such as life sciences or nursing.
- A minimum of two years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
- Strong organizational skills and attention to detail.
- Ability to work independently and collaboratively in a team environment.
- Excellent communication and interpersonal skills.
