Animal Health Clinical Research Associate III

🕒 May 29

🌪️ Kansas – Remote

🌪️ Kansas – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Argenta

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $30M Private Equity Round on 2021-05

Healthcare • Consulting • Manufacturing

Argenta is a global contract research, development, and manufacturing organization (CRO/CDMO) focused exclusively on animal health. They provide comprehensive services from drug development to regulatory and clinical services to manufacturing, employing a 'molecule to market' approach. Argenta partners with companies worldwide to develop and bring animal health pharmaceuticals and products to market. Their expertise includes regulatory guidance, clinical studies, and manufacturing support, delivering over a billion doses of animal health medicines annually. With a large team of scientists, veterinarians, and consultants and multiple EMA and FDA-approved manufacturing locations, Argenta is dedicated to advancing animal health through innovation, including the development of novel therapies like monoclonal antibodies and stem cells.

📋 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