Sr. Clinical Research Associate

Sr. Clinical Research Associate

Location: Boston, MA, US

Remote Work: 1-2 days at home (site based)

Company: Paragonix Technologies, Inc.

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

Position Overview

The Senior Clinical Research Associate oversees prospective randomized clinical studies across solid organ platforms at Paragonix Technologies. Reporting to the VP Scientific and Medical Affairs, the role focuses on data management, clinical operations, and ensuring studies comply with ICH GCP and internal SOPs.

Job Responsibilities and Essential Duties

• Provides data coordination and data management for randomized clinical studies.
• Manages investigative site activity for multiple protocols.
• Coordinates budgets and invoicing.
• Creates and implements subject enrollment strategies for assigned investigative sites.
• Ensures clinical trials are managed and executed following ICH GCP, regulations, the protocol, and company-specific SOPs.
• Designs CRFs and eCRFs for data acquisition and data entry.
• Works closely with sites to train and support data capture and cleaning, coordinating efficient corrections to the database, assisting with troubleshooting and site challenges.
• Defines necessary validations or reports to ensure quality and timeliness of data collection.
• Monitors study metrics and site performance using standard study management tools.
• Collaborates with the study team to prepare abstracts, manuscripts, and other materials for internal and external audiences.
• Participates in meetings with multidisciplinary teams both internally and externally to ensure successful and timely completion of deliverables.
• Supports reporting to clinicaltrials.gov including data review, quality control checks, and interim and final analysis.
• Ensures that the databases, study case report forms, and data analysis match the overall study goals.

Required Knowledge & Skills

• Minimum requirement of a Bachelor's Degree, preferably in health sciences or a related field.
• Minimum of 6+ years of clinical research associate experience, particularly supporting randomized clinical trials in the medical device or pharmaceutical industry.
• Experience in cardiothoracic clinical trials preferred.

Other Requirements

• Experience with data collection and project management tools.
• Critical attention to detail and accuracy.
• Excellent oral and written communication skills.
• Willingness to travel domestically/internationally 1%–20%.

Benefits

• Health, Dental, and Vision insurance benefits
• 401(k) plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Parental and Caregiver Leave
• Tuition Reimbursement

Equal Opportunity Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.