Clinical Research Associate I
hace 1 mes
We are seeking a Clinical Research Associate I to join our team in Spain. As a key member of our clinical development team, you will be responsible for performing site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory compliance.
About Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Responsibilities- Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Bachelor's degree in Life Sciences or related field.
- 1-3 years of experience in clinical research with focus on site management.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
The estimated salary for this position is €45,000 - €60,000 per year, depending on experience and qualifications.
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