Senior Clinical Research Associate - Central or Western US

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Oversee the management, monitoring, and closure of assigned clinical trial investigator sites.

• Ensure the safety of patients and the quality of study execution in compliance with relevant laws, GCP, and sponsor standards.

• Manage relationships with investigator sites and coordinate operational trial activities from site activation to database lock.

• Act as the primary contact for assigned investigator sites.

• Collaborate with Site Care Partners, study teams, vendors, and investigator sites.

• Provide development, coaching, training, and protocol support to sites.

• Conduct both onsite and remote/electronic monitoring for site initiation, routine assessments, and site closure.

• Monitor adverse events and serious adverse events while working alongside the Drug Safety Unit.

• Submit TMF documentation, site reports, follow-up letters, protocol deviations, and updates on recruitment and study progress.

• Identify and address site-related issues and formulate corrective and preventive measures.

• Resolve data queries and execute close-out activities for investigator sites.

• Oversee the receipt, handling, accounting, storage, and destruction of investigational products.

• Assist with database release and may engage in unblinded monitoring.

• Maintain knowledge of products, protocols, and therapy areas.

• Support patient safety, eligibility criteria, and clinical guidance.

• Lead efforts in quality-event remediation and audit CAPA activities.

⛳️ Requirements

• In-depth understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• A minimum of 2 years of relevant experience in clinical research site monitoring.

• Proficient in English and the native language(s) of the country of work.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are mandatory.

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or an equivalent qualification.

🏝️ Benefits

• Commitment to equal opportunity employment.

• Chance to contribute to therapies that enhance patient care and improve global health.