Sr CRA I with SSU experience - Sponsor dedicated - Based in Hungary
Employer · Syneos Health
Other health professional
Field inspectorFull-timeBudapest
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers.
Tasks
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form is accurate and complete.
- Performs investigational product inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File for accuracy, timeliness and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Understands project scope, budgets, and timelines for own and others' activities in the clinical team.
Conditions & benefits
Career development and progressionSupportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.Inclusive cultureCommitted to building an inclusive culture where you can authentically be yourself.