Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the management and oversight of clinical trials to ensure compliance with regulatory standards and study protocols. This position requires attention to detail and a thorough understanding of clinical research processes, as well as communication and coordination with various stakeholders involved in clinical studies.
Responsibilities
- Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and study protocols.
- Assist in the selection and initiation of clinical study sites.
- Conduct routine site visits, provide training to site personnel, and ensure the accuracy of data collection.
- Collaborate with cross-functional teams to facilitate the smooth execution of clinical trials.
- Review site performance and resolve any issues that may arise during the course of the study.
- Prepare and maintain accurate documentation related to site visits and trial progress.
Qualifications
- Bachelor’s degree in life sciences or a related field.
- Proven experience in clinical research or a similar role is preferred.
- Knowledge of FDA regulations, ICH guidelines, and GCP standards.
- Strong organizational and communication skills.
- Ability to work independently and as part of a team.
- Proficiency in data management and reporting software.
