Clinical Research Associate II; Extremities Specialty

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

• Friendly, open,andfunteam culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients’ lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k) retirement plan
• Paid holidays,including floating holidays,to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

The Clinical Research Associate will function as the main point of contact for assigned sponsored and investigator-initiated studies. The CRA II will perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs) including site GCP compliance, trouble shoot issues and facilitate resolution, and monitor safety at the site. The position will also conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits.

The CRA II will also act as a resource for new CRAs in setting a high standard for site management, data review, and SOP compliance. They will also assist, as needed, as a back‑up resource for other clinical projects within Clinical Operations and assume accountability for assigned study site performance and begin to support the CRM on project‑level tasks.

• Bachelor’s degree required 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 is a preferred
• Independent judgment, critical‑thinking skills and discretionary decision‑making skills.
• Ability to multi‑task and prioritize autonomously.
• Excellent written & oral communication and presentation skills
• Must be willing to travel (50% of the time)

The specific duties of the Clinical Research Associate II include but are not limited to:

• Interfaces with clinical sites/investigators on and off site as part of administrative site management to ensure compliance with protocols and regulatory compliance.
• Conducts site qualification, initiation visits, on‑site monitoring visits, co‑monitoring visits, and site closure visits of all phases of clinical trials. Assist with the resolution of data queries. Write site visit reports or reviewing monitoring reports provided by Contract Research Organizations (CRO).
• Performs CRA duties for more than one protocol or serves on more than one project…