Clinical Research Associate (Remote)

Responsibilities

• Conduct site qualification, initiation, routine monitoring, and closeout visits for clinical research studies
• Ensure clinical trials are conducted according to study protocols, GCP guidelines, FDA regulations, and applicable local requirements
• Review source documentation, informed consent forms, and regulatory documents for accuracy and compliance
• Maintain accurate monitoring reports and study documentation within required timelines
• Monitor patient recruitment, enrollment, retention, and protocol compliance
• Absorb and provide regular updates on site performance and study progress
• Support audit and inspection readiness activities
• Track study milestones and provide regular updates on site performance and study progress

Qualifications

• 4+ years of clinical research experience, preferably as a Clinical Research Associate or on-site monitoring
• CRA certification (ACRP, SOCRA, or equivalent)
• Experience in oncology, immunology, cardiology, neuroscience, or rare disease studies
• Experience working with electronic data capture (EDC) systems
• Familiarity with risk-based monitoring methodologies
• Knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes
• Experience monitoring Phase I-IV clinical trials preferred
• Proficiency with Microsoft Office Suite and Clinical Trial Management Systems (CTMS)
• Ability to travel up to 50% as required
• Bachelor's degree in Life Sciences, Biology, Nursing, Public Health, or a related field

Pay

Salary: $110,000 - $140,000 based on years of relevant experience

Benefits

• Medical
• Dental
• Vision
• 401k
• Sick leave required as by law
• PTO
• Holidays