Clinical Research Associate II, III

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

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.

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.

Argenta is currently looking to fill the role of Clinical Research Associate in our Shawnee, KS location. This is a remote eligible role.

• Collaborates in coordinating and conducting GCP and study protocol training at study sites and assures training is documented with the team
• Learns to establish rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
• Collaborates in the review of 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

• Mastery of Good Clinical Practice (GCP)

• Learns to evaluate Investigators and assists with the 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
• Participates in monitoring of assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation
• Coordinates and travels to study sites to conduct pre-study site evaluations, study initiation, interim monitoring, and study close out visits
• Assists in verifying owner consent, existence and maintenance of source documents, and inventory of Investigational Veterinary Product/Control Veterinary Product (IVP/CVP) at study sites
• Maintains an updated study site personnel listing
• Reviews medical records and identifies discrepancies (demographics, medical history, visits/procedures including unscheduled, adverse events, con meds, etc.)

• May serve as the main communication contact between Argenta Clinical and study site personnel
• Creates materials and documentation for the study
• 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
• Assists the Project Manager with monitoring study enrolment to ensure enrolment objectives are attained per the study timelines for the in-life phase of the study; responsible for communicating enrolment issues/concerns to the Project Manager
• Recommends actions to Argenta Clinical management regarding IVP/CVP and study materials management
• Delivers training with enthusiasm and professionalism

• Learns to assist with evaluation and testing…