Description
Syneos Health is seeking an experienced Clinical Research Associate (CRA) for a single-sponsor partnership 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
- Providing guidance on audit readiness and supporting preparation for audits
- May act as primary liaison with project site personnel or central monitoring associate
- May provide training or mentorship to 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
- Minimum three years of CRA experience in Germany
- Oncology experience
- Fluency in both German and English
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis