Senior Clinical Research Associate (Medtech)

TL;DR

Senior Clinical Research Associate (Medtech): Managing the operational execution of clinical studies from concept to completion with an accent on study monitoring, regulatory compliance, and site management. Focus on overseeing trial supplies, developing study-related documentation, and ensuring strict adherence to ICH-GCP and FDA regulations.

Location: Remote (USA)

Salary: $99,400 - $124,200 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology, women’s health, and organ health.

What you will do

• Execute clinical studies from concept to completion, ensuring trial timelines, costs, and quality metrics are met.
• Provide logistical support for study start-up, site qualification, initiation, monitoring, and close-out.
• Develop key study documents including protocols, informed consent forms, and ethics committee submissions.
• Manage contracting, budgets, and invoicing for clinical trial vendors and investigative sites.
• Oversee biospecimen collection, processing, shipment, and storage, including associated tracking.
• Train CROs, vendors, and investigators on study requirements and provide guidance on site issues.

Requirements

• BA/BS degree in life sciences, related field, or equivalent.
• Minimum 4 years of experience working on clinical studies in biopharma, diagnostics, or medical device fields.
• Must be based in the USA.
• Competency in SOPs, ICH-GCP, and FDA Regulations.
• Experience with clinical EDC systems and familiarity with Trial Master File (TMF) structure.
• Must pass a post-offer criminal background check and provide training records for HIPAA/PHI and GCP.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• 401k and commuter benefits.
• Free genetic testing and fertility care benefits for employees and immediate families.
• Pregnancy and baby bonding leave.
• Generous employee referral program.