Clinical Research Associate/Senior Clinical Research Associate

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

📋 Description

• Oversee site management, monitoring, and the close-out process of designated clinical trial investigator sites.

• Ensure the safety of patients and the high-quality execution of studies in compliance with relevant laws, GCP, and sponsor guidelines.

• Cultivate relationships with investigator sites and address any protocol-related challenges.

• Manage all clinical trial activities from site activation to database lock.

• Act as the main point of contact for the assigned investigator sites.

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

• Provide coaching and training for site personnel regarding protocols and compliance standards.

• Assist in site activation, patient recruitment, and enrollment efforts.

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

• Track adverse events and serious adverse events while working together with the Drug Safety Unit.

• Prepare and submit TMF documentation, site reports, follow-up letters, protocol deviations, and recruitment and study progress reports.

• Identify and rectify site issues and create corrective and preventive actions.

• Address data queries and carry out investigator site close-out procedures.

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

• Assist in database release and perform unblinded monitoring as appropriate.

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

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

• Lead Quality Event remediation and audit CAPA activities when necessary.

⛳️ Requirements

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

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

• Proficiency in English and the native language(s) of the country where you will be working is required.

• 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, medical background, or an equivalent qualification.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.