Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is seeking a Senior Clinical Research Associate to oversee clinical studies at investigative sites, supporting study execution from site qualification through closeout. The role focuses on monitoring, site management, protocol and regulatory compliance, data quality, and participant safety for CNS and rare disease trials.

Responsibilities

• Manage clinical research activities at investigative sites participating in Worldwide clinical studies
• Identify and assess potential research sites to support successful study execution
• Coordinate study start-up activities, including collection of regulatory documentation and support of contract and budget processes
• Conduct all types of monitoring visits: Pre-Site Selection Visits (PSSVs), Study Initiation Visits (SIVs),Interim Monitoring Visits (IMVs) and Closeout Visits (COVs)
• Train site personnel on protocol requirements, data collection processes, and safety reporting expectations
• Monitor site performance and provide ongoing support throughout study maintenance activities
• Ensure compliance with informed consent requirements, safety reporting obligations, and applicable regulatory standards
• Partner with sites and study teams to drive data quality, participant safety, and overall study success
• Support site closeout activities and ensure study requirements are completed at the conclusion of the trial

Skills

• Bachelor's Degree or a Nursing Degree, along with 5+ years as a regional, traveling Clinical Research Associate
• Required experience monitoring CNS and Rare Disease clinical trials
• Strong knowledge of clinical trial processes, site management, and regulatory requirement
• Experience in full-service monitoring preferred

Benefits

• Home-based role supporting sites across the Midwest of the United States.

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