Job Description:

• Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
• Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
• Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
• Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
• Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
• Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
• Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation
• Serves as the liaison between Argenta US Clinical and study site personnel
• Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor
• Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Builds relationships with key individuals and contributors in the organization and beyond

Requirements:

• 8+ years clinical trial monitor experience within a Clinical Research Organization or major Animal Health pharmaceutical company
• Proven experience in GCP late phase clinical trials in animal health
• Attention to detail and analytically driven
• Dependability, flexibility and ability to multitask and manage time effectively

Benefits:

• Health insurance
• Strong culture
• Professional development opportunities