Sr. Clinical Research Associate

Senior Clinical Research Associate supporting pre-market clinical studies of investigational drugs for the Fluorescence Imaging group. The role requires extensive knowledge of clinical research regulations, GCP, and drug trial management, with frequent travel to investigational sites for monitoring and compliance oversight.

Responsibilities

• Support clinical study start-up, management, and regulatory compliance through FDA approval
• Conduct co-monitoring visits at investigational sites for protocol compliance and data accuracy
• Perform source data verification and query resolution in EDC systems and case report forms
• Prepare and manage study documentation, eTMF, and clinical trial master files
• Assist with site qualification, initiation, interim monitoring, and close-out visits

Requirements

• Minimum 8 years related clinical research experience with BA/BS degree, or 6+ years with nursing degree
• Advanced knowledge of Good Clinical Practice (ICH/GCP) and FDA regulations for human subjects
• Experience implementing pharmaceutical and surgical trials with protocol and ICF development
• Proficiency with electronic data capture (EDC) systems and clinical trial management systems
• Ability to travel up to 40% to investigational sites
• Excellent communication and interpersonal skills with physicians and cross-functional teams
• Clinical research certification or relevant education preferred