Clinical Research Associate II: Site Management & Trials

Axogen, Inc.; Tampa (FL); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Health

Dental

Vision

Matching 401K

Paid Time Off

9 Paid Holidays + 3 Floating Holidays

Dependent Care FSAs

Medical FSAs

Tuition Reimbursement

Paid Parental Leave

Paid Caregiver Leave

Basic Life Insurance

Supplemental Life Insurance

Employee Stock Purchase Plan

Disability Insurance

Job summary

Axogen, Inc. in Tampa, FL is seeking a Clinical Research Associate II to be the main point of contact for assigned studies, ensuring site regulatory compliance and data integrity across phases.

The CRA II will monitor sites, conduct qualification visits, initiation visits, routine monitoring, and site close-outs while assisting with data queries and SOP adherence. You will also train site staff and manage documentation, supporting multiple protocols within Clinical Operations.

Qualifications

• Bachelor's degree in a scientific or biomedical engineering discipline.
• At least 3 years of Clinical Research Associate experience.
• Research experience in device, trauma, orthopedic, or reconstructive surgery preferred.
• Independent judgment and discretionary decision-making skills.
• Excellent written and oral communication and presentation skills.
• Willingness to travel up to 50%.

Responsibilities

• Interfaces with clinical sites/investigators to ensure protocol and regulatory compliance.
• Conducts site qualification, initiation, monitoring, co-monitoring, and close-out visits.
• Assists with data queries, CRA duties across multiple protocols.
• Prepares site visit reports and monitors reports from CROs.
• Leads site staff training and ensures SOP compliance.
• Manages documentation with CROs and study sites.

Skills

Independent judgment

Discretionary decision-making

Written & verbal communication

Multi-tasking

Presentation skills

Ability to travel

Education

Bachelor's degree in a scientific or biomedical engineering discipline

Job description

Axogen, Inc. in Tampa, FL is seeking a Clinical Research Associate II to be the main point of contact for assigned studies, ensuring site regulatory compliance and data integrity across phases.

The CRA II will monitor sites, conduct qualification visits, initiation visits, routine monitoring, and site close-outs while assisting with data queries and SOP adherence. You will also train site staff and manage documentation, supporting multiple protocols within Clinical Operations.