The Senior Clinical Research Associate (Sr. CRA) leads the monitoring and oversight of clinical trials to ensure adherence to study protocols, regulatory guidelines, and industry standards including ICH GCP. With a strong emphasis on quality and accuracy, the Sr. CRA conducts site visits, reviews data, and verifies that all trial activities meet required procedures and ethical standards.
Key Responsibilities
- Oversee the execution of clinical studies to confirm alignment with approved protocols and regulatory expectations
- Conduct on-site and remote monitoring visits to assess data completeness, source documentation, and compliance
- Ensure sites follow standard operating procedures and maintain accurate, auditable records
- Identify and resolve issues that may affect data integrity or participant safety
- Collaborate with cross-functional teams to support trial timelines and quality objectives
Qualifications
- Proven background in clinical trial monitoring and site management
- Thorough understanding of ICH GCP guidelines, FDA regulations, and global compliance standards
- Willingness and ability to travel up to 65%, including domestic and international locations as needed
- Strong organizational skills with attention to detail and a commitment to ethical research practices
Work Environment
This is a hybrid position with significant field work requiring up to 65% travel. The role supports a collaborative, mission-driven culture focused on advancing clinical science and improving global health outcomes.
Our Culture
We foster an inclusive environment where employees are valued, supported, and empowered. Our team is united by a shared dedication to integrity, excellence, and making a measurable difference in public health through responsible research.
