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Post date: 1 week 5 days ago
Job description:
Core responsibilities:

•Communication - Maintains timely and effective communication among team members and site staff. Anticipates/indentifies potential issues.

•Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations. (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor. SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines. and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested; may require guidance to. respond to findings. May be responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities.

•Monitoring - Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements;assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of a ...
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