Drafts protocols and reports for clinical studies on cosmetics or other claims.
Uses internal or client template, study outline, clinical data, International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, and other relevant information.
Coordinates internal and external protocol reviews and obtains client agreement
Writes and reviews ICH/GCP-adherent clinical study protocols, coordinates internal and external reviews, and obtains client agreement by project deadline
Drafts clinical study reports based on internal or client template according to clinical data, protocol and amendments and deviations; revises reports based on reviews by quality assurance, statistics department, investigators, client, and others
Assists in maintaining internal databases of protocol and report templates, bioinstrumentation specifications, clinical grading parameters, and client preferences
Assists in drafting and editing Standard Operating Procedures (SOPs) and Work Instructions (WI) for department as assigned
Completes training within required deadline
Adheres to internal standards, policies, and procedures