Sr. CRA, FSP - Surgical / Medical Device - Central region

Fortrea seeks an experienced Senior Clinical Research Associate with surgical/medical device expertise for site monitoring and management in the Central region. The role involves overseeing clinical trial sites, ensuring regulatory compliance, managing data integrity, and coordinating project activities with 60-80% travel.

Responsibilities

• Conduct routine monitoring, closeout activities, and initiation visits at clinical trial sites
• Verify informed consent procedures and protocol adherence according to regulatory requirements
• Review source documents and Case Report Forms to ensure data integrity and identify missing or implausible data
• Prepare trip reports and manage monitoring plans as lead monitor or under project direction
• Track and follow-up on Serious Adverse Event reporting, including narrative development and regulatory submissions

Requirements

• Bachelor's degree in life sciences or equivalent certification from accredited institution
• Three or more years of clinical monitoring experience
• One or more years of medical device trial experience
• Advanced site monitoring and site management skills
• Thorough knowledge of regulatory requirements and drug development processes
• Valid driver's license and ability to travel 60-80% overnight
• Advanced verbal and written communication skills in English