Hybrid Senior CRA: Data, Site Oversight & Compliance

Celgard; Cary (NC); Hybrid; USD 100,000 - 115,000; Full time

Job summary

Asahi Kasei Therapeutics is seeking a Clinical Research Associate to support sponsor-side operations, monitor trials, and manage data quality with limited travel. This in-house role emphasizes TMF oversight, site communication, and cross-functional collaboration.

Ideal candidates have a life science or clinical degree with 3+ years of monitoring experience, strong ICH GCP knowledge, and excellent communication and organizational skills to support trial timelines and compliance.

Qualifications

• Life science or clinical degree or equivalent experience.
• At least 3 years’ monitoring experience.
• Strong knowledge of ICH GCP and regulatory guidelines.

Responsibilities

• Assist with all phases of clinical trial activities (start-up, maintenance, close out).
• Review site monitoring reports to identify non-compliance and ensure sponsor oversight.
• Support essential document reviews and TMF management.
• Perform centralized data listings reviews and monitor study dashboards.
• Assist with CRO monitor performance and site engagement activities.
• Maintain study timelines, trackers, and QA of study materials.

Skills

ICH GCP

Independent work

Communication skills

Attention to detail

Problem solving

Prioritization

Travel-ready

Education

Life science degree

Tools

MS Office

Job description

Asahi Kasei Therapeutics is seeking a Clinical Research Associate to support sponsor-side operations, monitor trials, and manage data quality with limited travel. This in-house role emphasizes TMF oversight, site communication, and cross-functional collaboration.

Ideal candidates have a life science or clinical degree with 3+ years of monitoring experience, strong ICH GCP knowledge, and excellent communication and organizational skills to support trial timelines and compliance.