Senior Clinical Research Associate - IVD Trials

Bio-Rad Laboratories; Seattle (WA); On-site; USD 83,000 - 114,200; Full time

Benefits offered by this job

Competitive compensation package

Medical plans for you and family

Employee stock purchase plan

Life and disability insurance

401k plus profit sharing

Job summary

Bio-Rad Laboratories seeks a Clinical Research Associate II to plan, execute, and oversee clinical studies in accordance with ICH-GCP and IVD guidelines. Based in Seattle, you will collaborate across Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver robust clinical data for product registration and commercialization of Bio-Rad diagnostic products.

You will manage study budgets and timelines, monitor enrollment and data integrity, and ensure compliance while supporting

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).
• 2 years' experience in clinical research (clinical trials execution role, preferably in an IVD, device or pharma company).
• Experience using eTMF and EDC platforms during clinical research.
• Deep knowledge of FDA clinical research regulations, and ICH-GCP, ISO 13485, ISO 20916.
• Excellent written and verbal communication skills, and people management experience.

Responsibilities

• Manage clinical studies required for establishing IVD product performance.
• Author clinical performance monitoring plan, protocol, ICF, etc. in compliance with applicable regulations.
• Select, qualify and onboard clinical study sites with study agreements and IRB approvals.
• Foster effective communication and collaboration with study sites and CROs, and oversee study execution from initiation to closeout.
• Monitor study progress, enrollment, data integrity, risk management, and ensure compliance with GCP and regulatory requirements.

Skills

2 years clinical research experience

eTMF and EDC platforms

FDA regulations & ICH-GCP

ISO 13485 & ISO 20916 knowledge

Excellent communication skills

People management experience

Education

Bachelor's degree in Life Sciences or related field

Job description

Bio-Rad Laboratories seeks a Clinical Research Associate II to plan, execute, and oversee clinical studies in accordance with ICH-GCP and IVD guidelines. Based in Seattle, you will collaborate across Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver robust clinical data for product registration and commercialization of Bio-Rad diagnostic products.

You will manage study budgets and timelines, monitor enrollment and data integrity, and ensure compliance while supporting