Job Summary
The Clinical Research Associate, Sponsor Dedicated, plays a critical role in overseeing and managing clinical trials on behalf of sponsors. This position requires a detail-oriented individual who can ensure that the clinical studies adhere to regulatory requirements and that data integrity is maintained throughout the research process. The Associate will act as a primary contact between the sponsor and clinical sites, ensuring effective communication and smooth operational flow of the trials.
Responsibilities
- Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines.
- Review and assess site performance, project timelines, and budgets to guarantee successful trial execution.
- Collaborate with site personnel to provide training and support during the study to maximize compliance and efficiency.
- Conduct regular site visits to evaluate recruitment progress, patient safety, and data accuracy.
- Facilitate issue resolution between sites and sponsor while fostering a positive relationship with clinical teams.
Qualifications
- A bachelor’s degree in life sciences, nursing, or a related field is typically required.
- Prior experience as a Clinical Research Associate or in a similar position is highly preferred.
- Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements.
- Excellent communication and organizational skills to manage multiple projects effectively.
- Proficiency in clinical trial management software and Microsoft Office Suite.
