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At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together. TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply. Argenta, US Clinical is currently looking for an experienced Clinical Research Associate to join our team.
Job Responsibility:
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
Minimum of 8 years’ experience in an animal health research role, Monitor and Clinical Research Associate positions preferred
Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred
Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization
Ability to look for creative solutions to resolve complex issues
Strong technical writing ability
Results oriented and driven
Strong communication and listening skills
Well organized and analytically driven
Willingness to travel, expected to travel nationally 40 to 60%
What we offer:
opportunity to work for a successful and rapidly expanding global business where your input will be valued
support our people through strong culture, great benefits, and opportunity for growth