Description
Syneos Health is seeking a Senior Clinical Research Associate (Sr CRA) to work from home across Romania.
As a Sr CRA, you will perform site qualification, site initiation, interim monitoring, site management, 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 processes and protecting subject/patient confidentiality
- Assessing site processes and conducting source document reviews
- Resolving queries and providing guidance to site staff
- Managing site-level activities and communication to meet project objectives
- Preparing for and attending investigator meetings and sponsor face-to-face meetings
- Providing guidance on audit readiness standards and supporting preparation for audits
- May involve direct supervision, training, and mentorship of junior CRAs
Requirements:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to adapt to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Syneos Health offers a dynamic work environment where you can develop your skills and advance your career.