Sr. Clinical Research Associate (Breast 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 Sr. Clinical Research Associate
This Sr. CRA position will operate as the main point of contact for assigned sponsored study sites and investigator-initiated studies. The Sr. CRA will perform investigator set up and 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 Sr. CRA will assist with training and onboarding activities for new CRAs. The Sr. CRA will coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan. They assume accountability for assigned study site performance, providing high quality data, according to established timelines.
Requirements of the Sr. Clinical Research Associate
- Must have a bachelor’s degree in a scientific discipline at a minimum.
- Four years previous clinical research experience in Phase III –IV studies. Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred
- Strong knowledge of anatomy and physiology
- Experience with assisting in protocol design, study document creation, and database design/maintenance
- Capable of working on clinical monitoring issues of moderate scope
- Demonstrates the ability to build relationships with clinical sites/investigators to ensure compliance with protocols and regulatory requirements
- Ability to read and critically interpret relevant literature. Serve as a resource for clinical knowledge.
- Oral and written communication skills are essential
- Exercises judgment on routine clinical procedures and practices to determine appropriate action
- Strong interpersonal skills, exceptional organizational and time-management skills
- Ability to work independently and collaboratively in a team environment
- Ability to manage and coordinate CRA activities as needed for assigned study projects
- Ability to quickly adapt to changes in departmental priorities and goals to meet company strategies and directives
- Knowledge of GCP/IHC regulatory requirements
- Must be willing to travel (50% of time)
- Consistently anticipates and finds ways to overcome obstacles to achieving the goals
- Holds himself/herself accountable for taking tasks all the way to completion
- Can clearly communicate important company goals and what he/she needs to do in order to accomplish them
Responsibilities of the Sr. Clinical Research Associate
The specific duties of the Sr. Clinical Research Associate include but are not limited to:
- Assist with development and implementation of protocol design, study training documents, study documents, and plan management for sponsored and investigator initiated studies.
- Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical studies.
- Interfaces with clinical sites/investigators on-site and through off-site administrative site management to ensure compliance with protocols and regulatory compliance
- Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
- Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation)
- Conduct orientation and onboarding and training activities for new CRAs.
- Coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan.
- Assumes accountability for assigned study site performance, providing high quality data, according to established timelines.
- Assists Clinical Operations staff and study site staff to quickly identify, effectively resolve issues, and implement corrective and preventive actions.
- Assists with the development and maintenance of study databases
- Review, retrieve, and report study data as the requirements dictate or as appropriate
- Prepares reports of study progress to upper management
Location
111 West Oak Ave., Tampa, FL 33602
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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)