Facilitates project meetings with respect to the preparation and distribution of materials and final meeting minutes, as well as the coordination of participants.
December 26, 2019
Drafts and/or evaluates protocols, budgets and procedures regarding research projects and studies.
February 08, 2020
Sets up and maintains Study Oversight Files in compliance with ICH GCP and SOPs as per the Project Manager instructions.
March 22, 2020
Reports, appropriately, observed fraud or abuse.
March 28, 2020
Provides supervision and coordination of all regulatory activities, workflow and regulatory staff.
April 09, 2020
Serves as a resource to the institution, research staff and investigators regarding current and developing FDA regulations regarding the participation and protection of human research subjects.
April 23, 2020
Maintains knowledge of policies and procedures and performs in accordance with the Principles of Responsibilities and applicable regulatory requirements, external laws and accreditation standards.
April 25, 2020
Manages the process for ensuring appropriate documentation of all aspects of the clinical trials regulatory process ensuring accuracy and compliance with IRB, FDA, Good Clinical Practices, and federal and state regulations.
May 04, 2020
Develops, implements, and/or oversees orientation and education of investigators and research study staff in the regulatory process for biomedical research, in compliance with federal and local regulations.
July 03, 2020
Performs other duties as assigned by management.
July 16, 2020