Senior CRA, Breast Specialty — Impactful Clinical Trials

axogen; Tampa (FL); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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).

Connaissances

Clinical monitoring

Regulatory compliance

Oral & written communication

Relationship building

Anatomy & physiology knowledge

Team collaboration

Independent work

Formation

Bachelor's degree in a scientific discipline

Description du poste

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