Role Overview
This position supports the execution of clinical trials across Romania, with the flexibility to work remotely. As a Clinical Research Associate II, you will play a key role in monitoring trial sites, maintaining data quality, and ensuring compliance with international standards to advance medical research.
Key Responsibilities
- Perform site qualification, initiation, routine monitoring, and close-out visits to ensure study integrity.
- Verify adherence to study protocols, regulatory requirements, and patient safety standards.
- Collaborate with investigators and site personnel to support efficient trial operations.
- Review clinical data, identify discrepancies, and resolve queries to uphold data accuracy.
- Support the development and review of essential study documents such as protocols and clinical study reports.
Qualifications
- Bachelor’s degree in a life science, healthcare, or related discipline.
- At least two years of hands-on experience in clinical trial monitoring.
- Thorough understanding of ICH-GCP guidelines and regulatory frameworks governing clinical research.
- Strong attention to detail, organizational abilities, and clear communication skills.
- Proven ability to manage responsibilities independently while contributing to team objectives.
- Willingness to travel frequently—minimum 60% time on the road, including domestic and international trips requiring flying and driving.
- Valid driver’s license required.
Work Environment
This role is based in Romania with remote working options. The organization operates globally, supporting teams across regions with flexible arrangements. The culture emphasizes inclusion, professional growth, and sustainable business practices. Employees are encouraged to contribute to innovation while maintaining personal well-being and work-life balance.
Benefits
- Competitive salary and retirement planning options
- Comprehensive health insurance plans for employees and their families
- Generous annual leave policies
- Life assurance coverage
- 24/7 Employee Assistance Program via TELUS Health, providing access to mental health and well-being resources
- Flexible, country-specific benefits such as childcare support, gym discounts, travel subsidies, and health assessments
Equal Opportunity
All applicants are considered without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or veteran status. The organization is dedicated to fostering a workplace free from discrimination and harassment, where diverse perspectives are valued and inclusion is central to daily operations.
