Job Description
ABOUT THIS ROLEKey Accountabilities:Ensuring regulatory, ICH-GCP 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 significant 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 Standard Operating Procedures (SOPs)/processesVerifies the process of obtaining informed consent has been adequately performed and documented for each subject as requiredDemonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issuesPer the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations
Responsibilities + Skills
Education
Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMPEnsures all activities are managed by site personnel who are appropriately delegated and trained
Experience
