Description
Syneos Health is seeking an experienced Clinical Research Associate (CRA) to join their team in Germany.
The successful candidate 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 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 reconciling contents with trial master files
- Documenting activities and supporting subject/patient recruitment and retention
- Understanding project scope, budgets, and timelines to ensure objectives are met
- Acting as a liaison with project site personnel and providing guidance on audit readiness
- May provide training or mentorship to junior CRAs
The ideal candidate will have:
- A Bachelor's degree or RN in a related field or equivalent experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Previous monitoring experience in Germany
- Excellent communication, presentation, and interpersonal skills
- Fluency in English and German
- Ability to manage required travel of up to 75% on a regular basis