[Hiring] Clinical Research Associate @Argenta

Role Description

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

Key Responsibilities:

• GCP Requirements
  • 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.
• Site Management
  • 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.).
• Study Management
  • 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.
• Data Management
  • Learns to assist with evaluation and testing of the data entry system for the study, either paper-based or ED.
  • Learns to assist with and facilitate clarifications, corrections, and data query resolution with study sites or data management personnel.
  • Learns to assist the Project Manager with data entry support throughout the study.
  • Ensures the timely resolution of queries to obtain database lock to meet the established milestone.

Qualifications

• 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.
• Position requires significant computer skills including the ability to use Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
• The employee must possess a valid driver’s license and proper travel documentation i.e., passport, and have the 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.
• A collaborative working style to be able to lead and motivate people at all levels and across all functions in an organization.
• Strong analytical thinking and problem-solving skills.
• Capable of working in a changing environment and under pressure.
• Supports organizational goals and objectives aligned to strategic and/or operations plans.

Benefits

• Opportunity to work for a successful and rapidly expanding global business where your input will be valued.
• Strong culture, great benefits, and growth opportunities.

Company Description

Argenta is more than a company — we’re a global team, dedicated to healthier animals. 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 value diversity and believe that when everyone works together, we will make the lives of the animals we care for better.