Qualifications

• Bachelor's degree in Life Sciences or equivalent, or RN qualification
• Eligibility to work in the U.S. without visa sponsorship
• 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
• Experience across multiple therapeutic areas
• Proficient in ICH-GCP and clinical systems like CTMS and eTMF
• Strong communication and problem-solving skills
• Willingness to travel up to 50% for site visits in the Midwest region

Responsibilities

• Act as the primary contact between sites and the sponsor
• Conduct site visits including selection, initiation, monitoring, and close-out
• Ensure compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support site staff training and compliance record-keeping
• Monitor patient safety and report adverse events timely
• Facilitate site-level subject recruitment and retention effort
• Oversee drug accountability and ensure compliance with handling procedures
• Drive high-quality data entry and resolve data queries
• Document site progress, escalating risks or issues as needed
• Assist in tracking site budgets and ensuring timely payments
• Collaborate with cross-functional teams including CTAs, LTMs, and CTMs

Benefits

• Competitive base salary and performance-related incentives
• Health and wellbeing programs including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources
• Opportunities for professional growth through structured training and career pathways