北京招聘

1. Monitoring ？ Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Company and Sponsor SOPs. ？ Critically evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV). Plans and conducts study initiation visits for investigator sites. Applies planning techniques for monitoring visits to ensure efficient and effective monitoring. Plans and conducts study close-out visits for investigator sites. Manages and prioritizes workload effectively. ？ Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work. Maintains awareness of key study performance indicators for own sites. Supports subject recruitment and retention strategies. Updates study and subject status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact and anticipates/ identifies potential issues and implements corrective actions. Seeks guidance to resolve complex issues. ？ Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools. Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, bio sample management and subject reported outcomes instruments as applicable. Follows standard process for documentation of site contacts (visits, phone, email etc.). ？ Extensive travel may be required, 50% to 75% on a regular basis.

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