Clinical Research Associate II

Treace One, L.P. - Ponte Vedra Beach, FL

Full-time - Mid Level

Ponte Vedra Beach, FL

About the position

The Clinical Research Associate II will oversee clinical trial activities at investigational sites, ensuring compliance with study protocols and regulatory requirements. This role involves conducting site visits, generating reports, and supporting the development of clinical study documentation, all while maintaining the rights and well-being of human subjects.

Responsibilities

• Ensure compliance with study protocols, Good Clinical Practices (GCPs), and regulatory requirements during clinical studies.
• Act as the primary liaison to clinical sites, conducting remote and in-person site qualification and monitoring visits.
• Generate high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner.
• Contribute to the development of protocols, informed consent, case report forms (CRFs), and clinical study reports (CSRs).
• Maintain documentation of all clinical research activities in the trial master file (TMF).
• Drive trial enrollment and communicate potential obstacles to enrollment.

Requirements

• A minimum of 5 years of directly related work experience in clinical research, particularly in medical device trials and orthopedics.
• Strong knowledge of Good Clinical Practices (GCPs), FDA regulations, and IRB requirements.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
• Strong project management skills and attention to detail.
• Excellent verbal and written communication skills.

Nice-to-haves

• SUCRA/ACRP Certification preferred.
• Bachelor's degree in a science or related field preferred.

Benefits

• Confidentiality of personal information according to EEO guidelines.