Job Summary
The Clinical Research Associate II plays a vital role in the clinical trial process, responsible for overseeing the progression of study projects. This position involves ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the research lifecycle.
Responsibilities
- Conduct site visits to monitor the execution of clinical trials and ensure adherence to protocol guidelines.
- Evaluate trial documentation and report on study progress, identifying any irregularities.
- Facilitate communication between study sites and the sponsor, addressing inquiries and providing necessary support.
- Assist in the training and education of site staff on study protocols and processes.
- Contribute to the preparation and submission of study-related documents to regulatory authorities.
Qualifications
- Bachelor’s degree in a relevant scientific or healthcare field.
- Previous experience in clinical research, preferably as a Clinical Research Associate.
- Strong knowledge of Good Clinical Practice (GCP) and regulatory standards.
- Excellent organizational and communication skills, with the ability to work independently.
- Proficiency in managing multiple priorities and meeting deadlines effectively.
