Clinical Support Specialist I

UNKNOWN; Shawnee (KS); Vor Ort; USD 42.000 - 56.000; Vollzeit

Benefits dieser Stelle

Great benefits

Global team culture

Zusammenfassung

Argenta is seeking a Clinical Support Specialist I in Shawnee, KS to support clinical studies and data management. You will review records, assist with data QC, and help manage IVP/CVP inventory and labeling procedures.

The role requires a scientific background, familiarity with medical terminology, and strong organizational and communication skills. A team-focused environment with growth opportunities awaits.

Qualifikationen

• Bachelor’s degree or equivalent scientific experience.
• Experience with medical/veterinary terminology.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication with stakeholders.

Aufgaben

• Collaborate in reviewing study records and notebooks for currency and completeness.
• Assist with data tracking, QC, and responses to QA audits.
• Follow SOPs and study data management plans in electronic systems.
• Learn data entry and QC to ensure high-quality datasets.
• Coordinate with Project Managers on study needs and resources.
• Assist in IVP/CVP inventory management and labeling procedures.
• Help organize international shipments and regulatory compliance for studies.
• Provide general administrative support and assist on-site tasks as needed.

Kenntnisse

Bachelor’s degree

Medical/veterinary terminology

Communication skills

Attention to detail

Organizational skills

Problem-solving

Ausbildung

Bachelor’s degree in science

Tools

Microsoft Word

Excel

Adobe Acrobat

Jobbeschreibung

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.

TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.

Argenta is currently looking to fill the role of Clinical Support Specialist I in our Shawnee, KS location.

Key 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, 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, 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

About You:

• 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

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued.At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.

Argenta is an equal-opportunity employer

To find out more about Argenta, click here: www.argentaglobal.com