Animal Health Clinical Research Associate III
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