Description
Syneos Health is seeking an experienced CRA to join their single-client team in Germany.
The successful candidate will perform 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 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
- Acting as primary liaison with project site personnel
- Providing guidance on audit readiness standards
- May provide training or mentorship to junior CRAs
The ideal candidate will have:
- A Bachelor's degree or RN in a related field
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Previous monitoring experience in Germany
- Phase I experience would be a plus
- Fluency in German and proficiency in English
- Excellent communication 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.