Senior Clinical Research Associate (Level dependent on experience)

What You’ll Do

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP.
• Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection.
• Collect, review and track essential/regulatory documents.
• Participate in and complete all general and study specific training as required.
• Participate in investigator, client and project team meetings; may include presentations.
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials.
• Perform site management...