The Senior Clinical Research Associate II plays a key role in overseeing clinical trial monitoring activities across study sites in Romania, delivering high-quality execution within a Functional Service Provider (FSP) framework. This position ensures that clinical research is conducted in alignment with Good Clinical Practice (GCP), regulatory requirements, and sponsor standards through both on-site and remote oversight.
Key Responsibilities
- Lead monitoring activities, including site initiation, routine visits, and close-out, to verify data accuracy and protocol compliance
- Develop standardized monitoring tools, templates, and checklists to enhance consistency and efficiency
- Ensure complete and timely documentation of monitoring findings and follow-up actions
- Collaborate with data management, biostatistics, and regulatory teams to support end-to-end trial operations
- Identify and resolve data discrepancies, protocol deviations, and operational challenges
- Contribute to the development of clinical protocols, study plans, and monitoring strategies
- Train and mentor junior team members, providing ongoing guidance in monitoring best practices
- Oversee daily site operations, ensuring adherence to timelines, quality standards, and regulatory expectations
- Support the creation of reports and documentation required for regulatory submissions
- Help shape processes and policies that improve monitoring quality and trial efficiency
Qualifications
Candidates must hold a bachelor’s degree in a relevant scientific or healthcare field and bring 3–5 years of hands-on experience in clinical research. A solid understanding of clinical trial lifecycle management, GCP guidelines, and regulatory frameworks is essential. Strong analytical abilities, attention to detail, and effective communication skills are required to manage complex data and cross-functional collaboration.
Proficiency with clinical trial management systems and monitoring software is expected. Certification such as CCRP or equivalent is preferred. The ideal candidate thrives in a structured yet evolving environment, balances multiple priorities, and contributes to team development through leadership and knowledge sharing.
Work Environment & Culture
This role operates locally within Romania, supporting a globally integrated team. The organization fosters a culture of inclusion, authenticity, and continuous growth, emphasizing diverse perspectives and strategic innovation. Employees benefit from structured training, career advancement pathways, and recognition programs that support professional development. The environment encourages input, collaboration, and the use of emerging data and technologies to accelerate therapy delivery.
Commitment to diversity, equity, and inclusion is reflected in recruitment and employment practices, aligned with EU standards. Reasonable accommodations are provided to support accessibility and equitable participation.
