Clinical Trial Associate

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Summary

The primary responsibility is to provide in-house support and assistance to Clinical Project Managers (CPM) with the day-to-day activities pertaining to clinical trials conducted for new product license applications, line extensions for existing products, and post marketing commitments with a focus on managing study documentation for completeness and accuracy, tracking study progress, assisting with site management and contributing to recruitment strategies as needed. Duties will be carried out under the supervision of a CPM.

Key Responsibilities:

• Assist as required in the startup of clinical trials including support for investigator identification, investigator meetings, shipment of study supplies, collection of essential documents and preparation for site initiation
• Assist with routine communication to study sites and broader study team (Vendors including Clinical Research Organizations (CROs) and support functions)
• Support the CPM in development and/or improvement of study specific procedures and processes
• Preparation, collection, processing, tracking and filing of study-related documentation, information and materials according to Good Clinical Practices and Standard Operating Procedures
• Assignment and tracking of study team study specific training
• Assist in preparation for internal and external audits
• Handle queries or issues and when necessary, promptly triage to appropriate staff. Maintain appropriate systems including the Clinical Trial Management System (CTMS) to ensure adequate and accurate tracking of study progress, maintenance of study documentation and timely production of required reports
• Develop and maintain a basic working knowledge of relevant protocols
• Perform other project team duties as required or delegated by the CPM
• Act as a back-up for CPM
• Assist in reviewing regulatory documents for completeness and Good Documentation Practices
• Internal and external communication, including meeting minutes
• Help organize clinical team meetings

Qualifications:

• Comprehensive knowledge and understanding of Good Clinical Practices required
• Ability to maintain effectiveness under changing circumstances and priorities
• Excellent verbal and written communication and organizational skills required
• Microsoft Office software expertise (specifically in Project and PowerPoint)
• Meticulous attention to detail expected for this position
• Excellent command of spoken and written English. Other languages are a bonus

• Bachelors degree and 3-5 years of clinical experience in pharmaceutical, biotechnology or medical device company including CRO.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.