Description
Syneos Health is seeking an experienced CRA to join their team. As a CRA II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. You will ensure regulatory, ICH-GCP, and protocol compliance, and use your judgment and experience to evaluate site performance and provide recommendations.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Ensure regulatory, ICH-GCP, and protocol compliance
- Evaluate site performance and provide recommendations
- Verify informed consent process and document confidentiality
- Assess site processes and conduct source document reviews
- Apply query resolution techniques and provide guidance to site staff
- Manage investigational product inventory and reconciliation
- Review Investigator Site File and reconcile contents with Trial Master File
- Document activities and support subject recruitment and retention
- Understand project scope, budgets, and timelines
- Adapt to changing priorities and achieve goals
- Act as primary liaison with study site personnel
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
- Provide guidance on audit readiness standards
Qualifications:
- 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
- Fluency in German and English
- Excellent communication, presentation, and interpersonal skills
- Location in South-West Germany, with ability to support Swiss sites
- Ability to manage required travel of up to 75% on a regular basis