Job Summary
The Senior Clinical Research Associate (Sr. CRA) plays a crucial role in managing clinical trials and ensures that all procedures and regulatory requirements are strictly adhered to. This position involves overseeing study execution, maintaining quality standards, and providing guidance for research protocols. The Sr. CRA acts as a liaison between the clinical team, sponsors, and regulatory bodies, ensuring smooth communication and efficient project progression.
Responsibilities
- Oversee and coordinate clinical trial activities to ensure compliance with the study protocol.
- Monitor site performance and provide support to clinical research sites.
- Ensure adherence to regulatory guidelines and Good Clinical Practice (GCP).
- Conduct site visits to assess compliance and facilitate study-related training.
- Review and verify data for accuracy and completeness.
- Collaborate with cross-functional teams to ensure timely project delivery.
Qualifications
- A bachelor’s degree in life sciences or a related field; advanced degree preferred.
- Significant experience in clinical research, with a focus on monitoring and trial management.
- Strong understanding of GCP, regulatory requirements, and clinical development processes.
- Exceptional organizational and communication skills.
- Ability to work independently and as part of a multidisciplinary team.
- Proficient in using clinical trial management software and other relevant tools.
