Description
Syneos Health is seeking a Senior Clinical Research Associate (CRA) to work remotely from Romania.
The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Evaluating site performance and providing recommendations for site-specific actions
- Verifying informed consent processes and protecting subject/patient confidentiality
- Assessing site processes and conducting source document reviews
- Applying query resolution techniques and providing guidance to site staff
- Managing investigational product inventory and verifying dispensing and administration
- Reviewing investigator site files and ensuring compliance with regulations
- Documenting activities and supporting subject/patient recruitment and retention
- Understanding project scope, budgets, and timelines
- Acting as a primary liaison with project site personnel
- Providing guidance on audit readiness standards
- May provide training or mentorship to junior CRAs
Requirements:
- Bachelor's degree or RN in a related field or equivalent experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75%
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.