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Asahi Kasei
Asahi Kasei
H1B Visa SponsorConstructionFood & BeverageHealthcare
Asahi Kasei is a Japanese industrial group working across materials, chemicals, electronics, housing and construction, healthcare, and pharmaceuticals. Its research and commercial operations include semiconductor technologies, life sciences, medical devices, and energy solutions such as electrolysis and hydrogen production. The company combines industrial manufacturing with applied research, with sustainability and innovation shaping its work across diverse markets.
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Senior Clinical Research Associate – Cary, NC (Hybrid)

Support Asahi Kasei’s specialty pharmaceutical trials through centralized site oversight, clinical data review, Trial Master File quality, and CRO monitor performance management.

USUnited StatesNCNorth Carolina
$100,000 – $115,000 / year
HybridFull-timeSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Support clinical trials from start-up through maintenance and closeout
  • Review site monitoring reports for potential non-compliance, monitoring gaps, and sponsor oversight needs
  • Assist with essential document review
  • Conduct centralized reviews of clinical listings, EDC queries, protocol deviations, site metrics, and study dashboards
  • Help the Clinical Project Manager evaluate CRO monitor performance
  • Oversee site compliance, quality measures, scope, deliverables, and timelines
  • Maintain study tracking spreadsheets and databases
  • Manage the Trial Master File and verify required documents in investigator files
  • Engage sites proactively to support enrollment and milestone adherence
  • Manage assigned sites independently across compliance, deliverables, relationships, and issue resolution
  • Attend kick-off, investigator, monitor, and other trial meetings
  • Track study timelines and performance metrics while supporting issue resolution
  • Review informed consents, case report forms, study operations manuals, monitoring tools, and related materials
  • Monitor site progress toward data collection, source document verification, and query resolution targets
  • Ensure assigned sites submit safety reports on time
  • Contribute to clinical data listings reviews

Requirements

  • Degree in life science, an advanced scientific or clinical field, or equivalent education and experience
  • At least three years of clinical trial monitoring experience
  • Working knowledge of ICH GCP and applicable regional regulations, including FDA, EMEA, and PMDA requirements
  • Ability to work with limited supervision
  • Excellent written and verbal communication skills
  • Strong attention to detail and problem-solving ability
  • Adaptability when priorities change while maintaining quality
  • Self-directed approach to prioritizing and completing tasks and special projects
  • Ability to handle confidential information with integrity and discretion
  • Effectiveness working across functions and organizational levels
  • Willingness to travel domestically and internationally as needed
  • Proficiency with Microsoft Office, including Excel, Word, Outlook, and PowerPoint

Benefits

  • Hybrid work arrangement
  • Limited domestic and international travel for investigator meetings, site engagement, and oversight activities
  • Equal opportunity employment commitment
  • Support for a diverse workforce

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