Clinical Research Associate II

axogen; Tampa (FL); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Comprehensive benefits

Job summary

Axogen is seeking a Clinical Research Associate II to support clinical trials in device, trauma, orthopedic, or reconstructive surgery. The role focuses on managing investigator sites, ensuring GCP and regulatory compliance, and coordinating site visits across multiple sites.

The candidate will train investigators, review data for accuracy, and work with CROs to ensure proper documentation and safety reporting. Travel up to 50% is required.

Qualifications

• Bachelor's degree in a scientific or biomedical engineering field.
• Minimum 3 years of CRA experience, preferably in device or surgical trials.
• Willing to travel 50%.

Responsibilities

• Manage investigator sites and ensure GCP and regulatory compliance.
• Conduct site visits (qualification, initiation, monitoring, close-out).
• Support data accuracy and safety reporting.
• Serve as a site management resource, train investigators, review data, and coordinate documentation with CROs.

Skills

CRA experience

GCP compliance

Regulatory compliance

Site management

Communication skills

Travel readiness

Education

Bachelor's degree in a scientific or biomedical engineering field

Job description

Role Overview

Clinical Research Associate II supporting Axogen's clinical trials in device, trauma, orthopedic, or reconstructive surgery.

Responsibilities

Responsibilities include managing investigator sites, ensuring GCP and regulatory compliance, conducting site visits (qualification, initiation, monitoring, close-out), and supporting data accuracy and safety reporting.

The role entails acting as a site management resource, training investigators, reviewing data, and coordinating documentation with CROs.

Requirements

Requirements: Bachelor's degree in a scientific or biomedical engineering field; minimum 3 years of CRA experience, preferably in device or surgical trials; strong critical-thinking, communication, and multitasking skills. Must be willing to travel 50%.

Preferred

Preferred: experience in clinical trials within nerve repair or regenerative medicine.

High-Value

High-Value: involvement in device or surgical trials, GCP compliance, multi-site management, and experience with regulatory and safety monitoring.

Location and Compensation

Location: Tampa, FL; salary range $84,190–$105,237; eligible for an annual bonus and comprehensive benefits.