Senior Clinical Research Associate responsible for site monitoring, site management, and oversight of clinical studies at investigator sites. Ensures protocol compliance, data integrity, patient safety, and regulatory adherence while managing vendor relationships and project activities.
Responsibilities
Conduct routine and closeout monitoring visits; maintain study files and pre-study initiation documentation
Verify informed consent procedures and protocol adherence; review source documents for CRF data integrity
Manage SAE reporting, query generation, and resolution using data management systems
Lead small projects under supervision; prepare trip reports and coordinate with investigators and vendors




Train and mentor junior staff; conduct QC visits and feasibility assessments as assigned
Requirements
University or college degree in life science, or allied health certification/nursing/medical/laboratory technology
Minimum 3 years clinical monitoring experience in pharmaceutical or CRO
Thorough knowledge of regulatory requirements and drug development process
Fluent in local office language and English, both written and verbal
Advanced site monitoring and site management skills
Advanced registry administration skills
Valid driver's license

📌 Sr Cra I (Xico)
🏢 Fortrea
📍 Xico