Sr. Clinical Research Associate (Breast Specialty)

axogen; Tampa (FL); On-site; USD 90,000 - 140,000; Full time

Job summary

Axogen is seeking a Sr. Clinical Research Associate to serve as the primary contact for assigned sponsored sites and investigator-initiated studies.

The role covers site setup, ongoing monitoring, and ensure GCP compliance across trials, with training duties for new CRAs and collaboration with Clinical Research Managers to execute monitoring plans. The candidate should have a scientific bachelor's degree, at least four years in Phase III–IV clinical research, and strong communication and

Qualifications

• Bachelor's degree in a scientific discipline (minimum).
• Four years of clinical research experience in Phase III–IV studies; device/trauma/orthopedic/reconstructive surgery experience preferred.
• Strong knowledge of anatomy and physiology.
• Experience with protocol design, study document creation, and database design/maintenance.
• Ability to monitor clinical studies and communicate effectively with sites.

Responsibilities

• Assist with protocol design, study training documents, and study management for sponsored and investigator-initiated studies.
• Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits across all study phases.
• Interface with clinical sites and investigators to ensure protocol and regulatory compliance.
• Train and guide investigators and study coordinators; follow up on corrective actions.
• Prepare and track documentation for clinical sites (contracts, budgets, IRB documentation).

Skills

Clinical monitoring

Regulatory compliance

Oral & written communication

Relationship building

Anatomy & physiology knowledge

Team collaboration

Independent work

Education

Bachelor's degree in a scientific discipline

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 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

• 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 documentat