Description
Syneos Health is seeking a Clinical Research Associate to join their team in Bulgaria.
The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Evaluating site performance and providing recommendations for site-specific actions
- Verifying informed consent and protecting patient confidentiality
- Assessing site processes and conducting source document reviews
- Resolving queries and providing guidance to site staff
- Managing investigational product inventory and verifying dispensing and administration
- Reviewing investigator site files and trial master files
- Documenting activities and supporting subject recruitment and retention
- Collaborating with project teams and site personnel
Requirements:
- Bachelor's degree or RN in a related field
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Excellent communication and interpersonal skills
- Ability to manage required travel of up to 75%
Syneos Health offers a dynamic work environment, opportunities for career development, and a Total Self culture that encourages authenticity and well-being.