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 youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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 bachelors 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

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 thirdparty vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.