Company Overview: A pioneering biopharmaceutical company dedicated to advancing healthcare through innovative therapeutic solutions. Founded on a commitment to bridge the gap in neurological research, The company focuses on discovering and developing novel treatments for a range of neurological disorders.
Responsibilities:
Site Management:
- Initiate, monitor, and close clinical trial sites to ensure compliance with study protocols, regulatory requirements, and company standards.
- Conduct site initiation visits to provide training on study procedures and protocols.
Monitoring and Data Management:
- Perform routine monitoring visits to assess data accuracy, source document verification, and compliance with study protocols.
- Review and resolve data discrepancies and discrepancies between source documents and CRFs (Case Report Forms).
Regulatory Compliance:
- Ensure that all study activities are conducted in accordance with applicable regulatory requirements, including ICH-GCP, FDA, and local regulatory authorities.
Safety and Adverse Event Reporting:
- Monitor and report adverse events and serious adverse events in compliance with regulatory and company guidelines.
Documentation and Reporting:
- Maintain accurate and up-to-date documentation, including site visit reports, monitoring logs, and study correspondence.
- Prepare and submit study progress reports to internal stakeholders and regulatory authorities.
Collaboration and Communication:
- Foster effective communication and collaboration with investigators, site staff, and internal cross-functional teams.
- Participate in study team meetings and provide updates on-site activities.
Requirements:
- Bachelor's Degree in Science or a related field preferred.
- Minimum of 2 years' CRA or related experience
- Good understanding of GCPs (Good Clinical Practices)
- Highly methodical and organized, including time-management skills and changing priorities
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Able to take initiative and work independently; a sense of urgency in completing tasks
If you are a highly motivated and dedicated Clinical Research Associate, please apply with your CV attached.
