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.
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.
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.
Skills
As published by greenhouse · 15 questions · 3 written answers
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (4)
- Please provide your current zip code.
- What is the highest level of education you have completed and area of focus?
- How many years of experience do you have monitoring clinical trials?
- Are you local to Tampa or relocating to the area (this is not a fully remote role)?
Pick from a list (8)
- Are you over the age of 18 years old?
- Are you able to perform the essential functions of this position, with or without reasonable accommodation?
- Are you able to provide proof of your right to work in the US if hired?
- Do you now, or in the future, will you require sponsorship by Axogen to work in the US?
- Have you previously worked for Axogen?
- Do you have an active non-compete or similar agreement that might prevent you from being permitted to work with Axogen? If yes, please email a copy to: talentacquisitioninterviews@axogeninc.com.
- Are you able to travel up to 50%?
- APPLICATION ACKNOWLEDGMENT I acknowledge that I have read this Application for Employment. I acknowledge that I understood each and every question that was asked of me in the Application for Employment. I acknowledge that I was given the opportunity by Axogen to ask questions regarding the Application for Employment and the hiring process. I acknowledge that if Axogen employs me, I will be free to leave Axogen at any time for any reason and that Axogen is free to separate my employment at any time and for any reason without prior notice. I understand that this is called “employment at will,” and no one other than an officer of Axogen has the authority to alter this arrangement, to enter into an agreement for employment for a specified period of time, and/or to make any agreement contrary to the at-will nature of my employment. Furthermore, I understand that any such agreement that is contrary to the at-will nature of my employment must be in writing signed by an officer of Axogen. I acknowledge and understand that by submitting this application, Axogen may use some of the information stated in this application and my resume if provided to: conduct necessary background or credit checks, contact references and prior employers, verify licenses, or obtain any other relevant information deemed necessary. Further, if I am offered a position by Axogen, the job offer is contingent on the satisfactory completion of: a background check, a drug test, any job-related medical evaluation, any job-related quality training, proof of my legal identification, and authorization to work in the United States, and verification of any of the information that I provided. I acknowledge and affirm that the answers I have provided in this application and resume (if provided) for employment are true and accurate. I further acknowledge that I have not withheld any information that was requested of me in this application for employment. I understand and acknowledge that any misrepresentations, false statements, and/or omissions made by me in completing this application for employment may result in me not being considered for employment by Axogen and/or may lead to disciplinary action, up to and including the separation of my employment if discovered by Axogen after I have been hired. Therefore, I agree that if I am hired by Axogen, and I unknowingly wrote or later learn that something false or inaccurate is on this application, I am required to correct any and all inaccurate statements.
Written answers (3)
- Do you have any relatives or household members working at Axogen or an Axogen partner currently? If yes, who?
- What are your compensation expectations (please list salary or hourly rate and bonus/commission separately)?
- If you accept an offer of employment from us, we will need your legal name as it appears on your social security card or other legal documents. Please provide your legal name below, including any suffixes (ex. Jr., Sr., III)