Clinical Trial Assistant
Axogen, Inc.

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 Trial Assistant

The Clinical Trial Assistant is primarily responsible for administering Axogen's clinical systems, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities.

Requirements of the Clinical Trial Assistant

• Bachelor's degree in a medical, scientific, engineering, or computer systems discipline or a commensurate combination of training and experience
• Prior experience with industry sponsored clinical research is strongly preferred
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred
• Strong critical thinking and discretionary decision-making skills
• Strong organizational and time-management skills
• Ability to multi-task and prioritize autonomously in a fast-paced environment
• Excellent written & oral communication skills

Responsibilities of the Clinical Trial Assistant

The specific duties of the Clinical Trial Assistant include but are not limited to:

• Configuring study specific applications within Axogen's Clinical Trial Management System (CTMS)
• Scanning, uploading, and assigning metadata for legacy documents needing to be migrated into eTMF
• Setting-up study specific Trial Master Files
• Performing Quality Control (QC) reviews of essential study documents and Trial Master Files to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices
• Processing essential documents and ensuring they are correctly filed in the appropriate Trial Master File
• Tracking and reporting TMF health metrics
• Tracking and reporting study metrics; inclusive of start-up, data management, and contracting as needed
• Participating in GxP audits and related clinical compliance
• Interfacing with study personnel (as needed) to ensure compliance with the study protocol, applicable regulations, and Good Clinical Practices
• Track, process, and organize various study supplies and shipments
• Under direct guidance, assist with coordination of basic study activities
• Preparing and tracking essential study documents (contracts, budgets, IRB documentation)
• Assisting with information gathering, literature searches, and creation of presentations as needed
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities
• Assist with vendor management and associated logistics, as assigned
• Assist in creating and implementing departmental
• Other projects and duties as required/assigned

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.

Salary Range

$51,505 - $64,381 USD

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.

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