Sr. Clinical Research Associate (Medtech)

TL;DR

Sr. Clinical Research Associate (Medtech): Overseeing prospective randomized clinical studies for organ transportation and preservation devices with an accent on data coordination and investigative site management. Focus on ensuring ICH GCP compliance, designing eCRFs, and optimizing subject enrollment strategies to maintain high data quality and study timelines.

Location: Must be based in the US; Hybrid (Boston, MA) with 1-2 days at home

Salary: $110,000 – $125,000 plus 10% annual bonus

Company

hirify.global (through Paragonix Technologies) develops and markets innovative organ transportation and preservation devices to improve donor organ quality and extend transport time.

What you will do

• Provide data coordination and management for prospective randomized clinical studies.
• Manage investigative site activity and coordinate budgets and invoicing across multiple protocols.
• Create and implement subject enrollment strategies for assigned investigative sites.
• Design CRFs and eCRFs for data acquisition and coordinate database cleaning and troubleshooting.
• Ensure clinical trials are executed in strict accordance with ICH GCP, regulations, and company SOPs.
• Collaborate with multidisciplinary teams to prepare abstracts, manuscripts, and reporting for clinicaltrials.gov.

Requirements

• Bachelor's Degree, preferably in health sciences or a related field.
• 6+ years of clinical research associate experience supporting randomized clinical trials in medical device or pharmaceutical industries.
• Must be based in the US.
• Ability to travel domestically and internationally (1% - 20%).

Nice to have

• Experience in cardiothoracic clinical trials.
• Proficiency with data collection and project management tools.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Tuition reimbursement and wellness initiatives.
• Hybrid work environment with 1-2 days at home.