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We are seeking a highly skilled Clinical Research Associate to join our team at Importante Empresa. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Evaluate overall site performance and provide recommendations for site-specific actions.
- Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs.
- Assess site processes, conduct source document review, and verify clinical data accuracy and completeness.
- Apply query resolution techniques and provide guidance to site staff as needed.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Ability to work independently and as part of a team.
- A comprehensive benefits program encompassing physical, mental, and financial well-being.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.