- Perform monitoring and site management activities for Phase I - IV clinical research projects to assess the progress of clinical projects at assigned investigative / physician sites to ensure clinical projects are conducted, recorded, & reported in accordance with protocol.
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and / or 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.
- Other duties / responsibilities as assigned.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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