Manages the collection, review and approval of regulatory documents from clinical sites and ensures ongoing maintenance of records throughout study lifetime.
January 27, 2020
Assists Principal Investigators with management of study activities, including assisting in the coordination of conference calls, preparation of a quarterly newsletter, and interface with data management team and performance sites.
February 04, 2020
Performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines.
March 30, 2020
Participates and provides input in interdepartmental, industry, and international project teams as the regulatory representative interpreting and applying regulations, guidelines, research/information available, and policies to enable the team to select the most effective start up.
April 09, 2020
Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record.
May 28, 2020
Provides guidance to investigators and study teams regarding completion of regulatory submissions including SRC/IRB applications, amendments, and annual continuing reviews.
June 03, 2020