Clinical Research Associate I, II, III

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🔥 0 minutes ago

🌪️ Kansas – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Argenta

Argenta

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

• Collaborate in coordinating and conducting GCP and study protocol training at study sites and ensure training is documented • Establish rapport with study site staff and support compliance with protocols, regulations, guidance documents, SOPs, and study activities • Review study records and notebooks for completeness and currency • Provide data tracking and quality control and assist with QA audit responses • Evaluate investigators and assist with selecting appropriate study sites • Collaborate with the Project Manager to ensure selected sites meet protocol needs • Monitor assigned study sites using EDC systems and faxed, emailed, and paper documentation • Coordinate and travel to sites for pre-study evaluations, initiation, interim monitoring, and closeout visits • Verify owner consent, source documents, and IVP/CVP inventory • Maintain study site personnel listings • Review medical records and identify discrepancies • Serve as a communication contact between Argenta Clinical and study site personnel • Create study materials and documentation • Track adverse events and ensure appropriate documentation and communication • Assist the Project Manager with monitoring enrolment and communicating enrolment issues • Recommend actions regarding IVP/CVP and study materials management • Deliver training professionally • Assist with evaluation and testing of data-entry systems • Facilitate data clarifications, corrections, and query resolution • Assist with data-entry support throughout studies • Ensure timely query resolution to achieve database lock and study milestones

🎯 Requirements

• Bachelor’s degree, preferably in a scientific discipline or equivalent experience • Minimum of 2 years’ experience in a scientific discipline and/or veterinary/veterinary technician experience • Experience in Good Clinical Practice (GCP) data management, quality control and/or quality assurance is preferred • Experience with medical/veterinary terminology • Prior Clinical Research Associate I role or equivalent experience and training • Experience working with EDC systems (Electronic Data Capture) is a plus • Significant computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat • Valid driver’s license and proper travel documentation, including passport • Ability to travel • Excellent oral and written communication skills • Ability to take an assertive approach when needed to keep sites on track with training, documentation, and query resolution • Collaborative working style to lead and motivate people at all levels and across all functions • Strong analytical thinking and problem-solving skills • Ability to work in a changing environment and under pressure • Supports organizational goals and objectives aligned to strategic and/or operations plans

🏖️ Benefits

• Strong culture • Great benefits • Growth opportunities • Equal-opportunity employer

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