Asahi Kasei

Sponsor pentru viza H1B Alimente și băuturi Asistență medicală Construcții

Asahi Kasei este un grup industrial japonez care activează în domeniile materialelor, produselor chimice, electronicii, locuințelor și construcțiilor, serviciilor de sănătate și produselor farmaceutice. Activitățile sale de cercetare și comerciale includ tehnologii pentru semiconductori, științele vieții, dispozitive medicale și soluții energetice precum electroliza și producția de hidrogen. Compania combină producția industrială cu cercetarea aplicată, iar sustenabilitatea și inovația îi modelează activitatea pe piețe diverse.

Locurile de muncă ale companiei

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.

acum 4 săptămâni

Statele Unite ale Americii

Carolina de Nord

100.000 $ – 115.000 $ / an

Hibrid Normă întreagă Senior Limbă Obligatorie: engleză Cercetare clinică

Google Cloud Platform

Descriere

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

Cerințe

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

Beneficii

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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