Sr. Clinical Research Associate

Getinge; Boston (MA); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

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

Job summary

Getinge is hiring a Senior Clinical Research Associate based in Boston, MA. The role focuses on overseeing clinical studies, ensuring compliance with regulatory protocols, and managing data collection for clinical trials.

The ideal candidate will have a Bachelor's in health sciences and over 6 years of experience in clinical research, particularly in the medical device industry. The position includes health benefits, a 401(k) plan, and paid time off.

Qualifications

• Minimum of 6+ years of clinical research associate experience, particularly in the medical device or pharmaceutical industry.
• Experience in supporting randomized clinical trials is required.
• Preferred experience in cardiothoracic clinical trials.

Responsibilities

• Oversees prospective randomized clinical studies across solid organ platforms.
• Ensures studies comply with ICH GCP and internal SOPs.
• Manages investigative site activity for multiple protocols.

Skills

Clinical research associate experience

Data management

Attention to detail

Communication skills

Education

Bachelor's Degree in health sciences or related field

Tools

Data collection tools

Project management tools

Job description

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.