Animal Health Clinical Research Associate III
Argenta
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. Our uniqueness means:- We are ambitious, growing and building a 'one team' culture, guided by our values.
- We are team players;
- We are doers;
- We are customer-centric;
- We are innovators.
Argenta, US Clinical is currently looking for an experienced Clinical Research Associate to join our team. You may be an excellent fit for our team if you have the following:
- 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
- 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
- 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%
Vacancy posted 5 days ago
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