Clinical Research Associate Senior I
hace 4 semanas
Job Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization building customer success through unique clinical, medical affairs and commercial insights. We accelerate outcomes to address modern market realities by putting the customer and patient at the center of everything we do.
As a Clinical Research Associate Senior I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory compliance and protocol adherence. You will use your judgment and experience to evaluate site performance and provide recommendations to the project team, immediately escalating serious issues.
Maintaining a working knowledge of ICH/GCP guidelines, relevant regulations and company SOPs, you will verify informed consent processes and assess factors affecting subject safety and clinical data integrity.
We are agile and driven to accelerate therapy delivery, passionate about developing our people through career development and progression, technical training and peer recognition.
- 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.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
- 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.
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