Clinical Support Specialist I

Argenta•Shawnee, KS

4d•Onsite

About The Position

Argenta is seeking a Clinical Support Specialist I for its Shawnee, KS location. This role involves collaborating on study record reviews, assisting with data tracking and quality control, and performing data entry and quality checks using an internal database or electronic data capture system. The specialist will learn to manage inventory, communicate with clinical teams, coordinate shipments, and maintain central files. This position offers an opportunity to work in a growing global business with a strong culture and valuable input, supporting the company's mission of healthier animals.

Requirements

Bachelor’s degree, preferably in a scientific discipline or equivalent experience
Experience with medical/veterinary terminology
Significant computer skills including the ability to use Microsoft Word, Excel, and Adobe Acrobat
Outstanding accuracy, attention to detail, and organizational skills
Quality interpersonal, communication and presentation skills; verbal and written communication with internal and external stakeholders must be clear and concise
Action and results oriented with strong problem-solving skills
Understanding of regulations
Capable of working in a changing environment and under pressure
Supports organizational goals and objectives aligned to strategic and/or operations plans
Gathers key information essential to the planning and process of clinical trial management
Works collaboratively with key stakeholders to streamline operations for maximum efficiency, automation, and effectiveness where appropriate.
Actively listens to ensure understanding
Explains issues and interprets data in understandable terms and adapts communication to target audiences

Responsibilities

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.
Follows established standard operating procedures and/or study specific data management plan using an internal database or electronic data capture system.
Learn to perform first and second data entry while utilizing science/veterinary background to ensure high quality of dataset.
Learn to perform QC by reviewing entries for accuracy and completeness versus hard copy case report form or copies.
Learn to review Project needs with Project Manager and coordinate tracking and study support resources.
Learn all aspects of IVP/CVP inventory for specific project(s).
Assist in communicating directly with study Clinical Research Associates, Project Managers, and clinical site personnel regarding IVP/CVP handling.
Learn to coordinate and maintain IVP/CVP accountability.
Learn to write study specific IVP/CVP labelling and handling procedures per Sponsor instructions.
Assist in organizing international IVP/CVP shipments with Sponsor and couriers, ensuring regulatory and country specifications are met.
Assist in shipping IVP/CVP to clinical sites.
Learn to perform final IVP/CVP accountability and ship IVP/CVP to Sponsor or designated company.
Assist Clinical Research Associates, Project Managers, Head of Clinical Services, Head of Clinical Operations, Clinical Support Manager, and Manager of Clinical Services with designated tasks (protocol/form development, SOPs, tables/listings for Final Study Report, etc.).
Learn to maintain Central Files including organization and filing of documents on a regular basis.
Learn to scan, bookmark, and QC of documents in preparation for submission of study specific data.
Work with Project Managers to determine study start up needs.
Learn to facilitate and create/QC of study materials, e.g., study notebooks, computer tablets, Owner folders, etc.
Assist in shipment of study materials, study documentation, electronic data, to Sponsor at study completion.
Provide miscellaneous administrative support, e.g., answering telephones, scanning documents, filing, preparing FedEx shipments, photocopying, etc.
May shadow and assist a Clinical Research Associate with specific tasks during initiation, interim, and close-out visits.