--- title: 'Clinical Research Associate II (Extremities Specialty) at Axogen' canonical: 'https://feeny.ai/job/clinical-research-associate-ii-extremities-specialty-axogen-tampa-vk5p60d10ws2' type: 'job' last_seen: '2026-10-28' --- # Clinical Research Associate II (Extremities Specialty) at Axogen - **Company:** Axogen - **Location:** Tampa, FL - **Compensation:** $84k–$105k - **Posted:** 2026-10-16 - **Last confirmed live:** 2026-10-28 - **Apply:** https://www.axogeninc.com/about-axogen/careers/?gh_jid=8886970002 ## Job description 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. Why you’ll love working at Axogen: - Friendly, open, and fun team culture that values unique perspectives - Company-wide dedication to profoundly impacting patients’ lives - Comprehensive, high-quality benefits package effective on date of hire - Educational assistance available 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 Axogen Mission and Business Purpose 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. Job Summary of the Clinical Research Associate II 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. ## Requirements of the Clinical Research Associate II - 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) ## Responsibilities of the Clinical Research Associate II 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 team. - Serves as a back-up resource for other clinical studies in Clinical Operations. - Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by providing: site training; guidance of investigators and site study team; and follow-up of corrective actions. - Ensures International Conference on Harmonization, and Good Clinical Practice procedures are followed in all study aspects. - Reviews study data for completeness, accuracy and consistency with study protocol. - Ensures timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study goals. - Ensures timely, accurate collection of all adverse events, adverse reactions, and complaint reports, and implement follow-up actions. - Prepares reports of study progress to upper management - Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation). - Assists with information gathering, literature searches, data analysis, report generation, and creation of presentations. - Assists with the development and maintenance of study databases. - Assists with preparation and execution of Investigator meetings, including participation in presentation of study updates. - Assists, as needed, with orientation and onboarding and training of new CRAs - Autonomously manages assigned sites and independently offers solutions to issues - Assists in identifying and resolving solutions to project-level issues - Manages documentation issues with CROs and/or study sites. - Complies with all company policies, procedures, and SOPs. - Other projects and duties as required/assigned. Location 111 West Oak Ave., Tampa, FL  33602 ## #LI-AC1 ## Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range $84,190—$105,237 USD Company Statements Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion. As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen. No agency solicitation. We kindly request that recruiting agencies, staffing firms, and third‑party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered. ## About Axogen ## Company Overview - **One-liner**: Axogen is a medical technology company focused on the science, development, and commercialization of products for peripheral nerve regeneration and repair, aiming to make restoration of nerve function an expected standard of care. - **Entity Type**: Public (NASDAQ: AXGN) - **Headquarters**: Alachua, Florida, United States - **Founded**: Not publicly available in provided sources - **Founders**: Not publicly available in provided sources ## Core Business - **Primary industry/industries**: Medical devices and biologics for peripheral nerve repair (surgical technologies) - **Target customers**: B2B – hospitals, surgeons, and healthcare providers (orthopedic, plastic, neuro, and hand surgeons) - **Mission statement**: “To restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.” [axogeninc.com/about-axogen](https://www.axogeninc.com/about-axogen/) ## Products & Services Axogen offers a comprehensive portfolio of implantable biologic and extracellular matrix products for peripheral nerve repair and protection: - **Avance® (acellular nerve allograft)**: An FDA-approved scaffold for bridging nerve gaps; approved as a biologic (BLA) in December 2025 for sensory, mixed, and motor nerve discontinuities. [ir.axogeninc.com](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm) - **Avance® Nerve Graft**: A biologically active processed human nerve allograft for bridging severed peripheral nerves without a second surgical site (being transitioned to Avance under BLA). - **Axoguard Nerve Connector®**: A porcine-derived extracellular matrix coaptation aid for tensionless repair of severed nerves. - **Axoguard Nerve Protector®**: A wrap used to protect and reinforce damaged peripheral nerves. - **Axoguard HA+ Nerve Protector™**: A next-generation product with a hyaluronate-alginate coating for enhanced gliding and protection. - **Axoguard Nerve Cap®**: Designed to protect the nerve end and reduce symptomatic neuroma formation. - **Avive+ Soft Tissue Matrix™**: A multi-layer amniotic membrane allograft for soft tissue separation and protection during healing. All products are classified as surgical implants (HCT/P or biologic), used in operating rooms. ## Market Standing - **Valuation/Market Cap**: Aggregate market value of non-affiliate held common equity was approximately **$430.7 million** as of June 30, 2025 (based on last reported sale price). [ir.axogeninc.com](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm) - **Key Metric**: Invested **$32.9 million in R&D** during fiscal year 2025; **138 direct sales professionals** in the U.S. as of December 31, 2025. - **Notable Investors/Partners**: Not publicly disclosed in provided materials. The company participates in major industry conferences (e.g., 2026 Bank of America Global Healthcare Conference). [ir.axogeninc.com](https://ir.axogeninc.com/) - **Growth Signals**: - FDA Biologics License Application (BLA) approval for Avance in December 2025, unlocking a regulated biologic pathway and a new manufacturing facility in Vandalia, Ohio. - Significant reimbursement improvements: Medicare outpatient payment for nerve allograft repair increased 96% over 2019 (221% in ambulatory surgery centers). - Over 350 peer-reviewed clinical publications supporting product use. - Expanding sales force and hybrid agency model; international sales in Canada, Germany, UK, Spain, and other countries. ## Competitive Advantages - **Single-focused leadership**: Axogen is the only company exclusively dedicated to peripheral nerve repair, with the most comprehensive portfolio on the market. - **Regulatory moat**: First and only FDA-approved biologic (BLA) for nerve allograft (Avance), creating higher barriers to entry. - **Strong clinical evidence**: >350 peer-reviewed studies and a robust post-market study requirement that will differentiate efficacy versus nerve autograft. - **Favorable reimbursement**: Dedicated Category I CPT codes (64912/64913) and CMS payment enhancements reduce economic barriers for hospitals. - **Established sales force**: Large direct team plus independent agencies covering remote geographies. ## Strategic Focus - **Product commercialization**: Launch Avance under BLA in early Q2 2026 and complete the transition from the previous 361 HCT/P framework. - **Confirmatory studies**: Fulfill FDA post-marketing requirement for Avance in mixed/motor nerve gaps (study due by 2030). - **Sales expansion**: Increase sales force productivity and add new accounts, especially in underpenetrated markets (oral maxillofacial, breast reconstruction neurotization, urology). - **International growth**: Expand geographic presence beyond current countries. - **Manufacturing scale**: Utilize the new Vandalia, Ohio facility to support anticipated growth. ## Why Work Here - **Mission-driven culture**: Employees are empowered by the “gift of human tissue” to restore nerve function and improve quality of life for patients. [axogeninc.com/about-axogen/careers](https://www.axogeninc.com/about-axogen/careers/) - **Core values**: Think Like a Customer, Encourage Innovation and Risk-Taking, Embrace Collaboration, Never Forget Our Purpose, Lead by Example. - **Work environment**: Headquarters in Alachua, Florida (near Gainesville); additional facilities in Vandalia, Ohio. Hybrid/office policy not explicitly stated but on-site presence likely for R&D, manufacturing, and sales support. - **Engineering & scientific culture**: Heavy investment in R&D (over $32M/yr) and clinical research; opportunity to work on cutting-edge regenerative medicine products. - **Growth trajectory**: Rapidly growing company with recent FDA approval and expanding commercial reach, offering career advancement potential. ## Sources 1. [axogeninc.com/careers - Culture and values](https://www.axogeninc.com/about-axogen/careers/) 2. [axogeninc.com - Company overview and mission](https://www.axogeninc.com/) 3. [axogeninc.com/about-axogen - Leadership and commitment](https://www.axogeninc.com/about-axogen/) 4. [ir.axogeninc.com - Investor relations, financials, and press releases](https://ir.axogeninc.com/) 5. [ir.axogeninc.com - 10-K Annual Report for FY2025](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm) ## Other roles at Axogen - [Field Access & Reimbursement, Sr. Manager - Extremity/OMF Specialty (Western US)](https://feeny.ai/job/field-access-reimbursement-sr-manager-extremity-omf-specialty-western-us-axogen-a06b9tgcmb1k) - [Area Sales Manager - Toledo, OH](https://feeny.ai/job/area-sales-manager-toledo-oh-axogen-toledo-8j9ghjq5gkxn) — Toledo, OH - [Director, Enterprise Data & AI Strategy](https://feeny.ai/job/director-enterprise-data-ai-strategy-axogen-tampa-67kgr5nraj5v) — Tampa, FL - [Area Sales Manager - Rochester/Upstate NY](https://feeny.ai/job/area-sales-manager-rochester-upstate-ny-axogen-buffalo-z80d8d7sek2j) — Buffalo, NY / Rochester, NY / Syracuse, NY - [Supervisor, Operations (Tissue Processing) - 3rd shift](https://feeny.ai/job/supervisor-operations-tissue-processing-3rd-shift-axogen-vandalia-2a0tjfzr6fms) — Vandalia, OH - [Sr. Clinical Research Associate (Breast Specialty)](https://feeny.ai/job/sr-clinical-research-associate-breast-specialty-axogen-tampa-jhh8zxwsdqbt) — Tampa, FL - [Area Sales Manager - Denver, CO](https://feeny.ai/job/area-sales-manager-denver-co-axogen-denver-hsc8pw0a1f9q) — Denver, CO - [Processing Technician- 2nd shift](https://feeny.ai/job/processing-technician-2nd-shift-axogen-vandalia-j01nhsvgerw8) — Vandalia, OH - [Construction Delivery Lead - GMP Facility & Projects](https://feeny.ai/job/construction-delivery-lead-gmp-facility-projects-axogen-vandalia-dzaajp97cysb) — Vandalia, OH - [Supervisor, Operations (Warehouse & Materials) - 2nd shift](https://feeny.ai/job/supervisor-operations-warehouse-materials-2nd-shift-axogen-vandalia-pc1dfnqd04fz) — Vandalia, OH