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Clinical Research Associate
hace 2 meses
Novasyte is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the quality and integrity of clinical trials by conducting site monitoring visits, administering protocol training, and evaluating site practices.
Key Responsibilities- Perform site monitoring visits to ensure compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Administer protocol training to assigned sites and establish regular communication to manage project expectations and issues.
- Evaluate the quality and integrity of study site practices and escalate quality issues as necessary.
- Manage the progress of assigned studies by tracking regulatory submissions, recruitment, and data query resolution.
- Ensure accurate documentation of site management, monitoring visit findings, and action plans.
- Collaborate with study team members to support project execution.
- High School Diploma or equivalent degree in a scientific discipline or healthcare preferred.
- 6 months of experience in site monitoring or 3 years as a Study Coordinator.
- Basic knowledge of clinical research regulatory requirements and GCP/ICH guidelines.
- Excellent communication, organizational, and problem-solving skills.
- Ability to establish and maintain effective working relationships.
Novasyte is a leading provider of clinical research services to the life sciences industry. We are committed to pushing the boundaries of human science and data science to create a healthier world.
