Clinical Research Associate (I, II, III)

Argenta•Shawnee, KS

2d•Remote

About The Position

Argenta is currently looking to fill the role of Clinical Research Associate in our Shawnee, KS location. This is a remote eligible role. Argenta is a global team dedicated to healthier animals, supporting companies in developing and manufacturing health products for pets and livestock. As the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health, Argenta is ambitious, growing, and building a 'one team' culture guided by its values: team players, doers, customer-centric, and innovators. The company values diversity and believes that when everyone works together, the lives of animals can be made better. This role is for individuals who are team players, want to do great work, and find innovative ways to improve animal lives through customer-centric efforts.

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
Mastery of Good Clinical Practice (GCP)
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
Significant computer skills including the ability to use Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

Nice To Haves

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

Responsibilities

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.
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 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.