Drafts and/or evaluates protocols, budgets and procedures regarding research projects and studies.
May 08, 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.
May 21, 2020
Reports, appropriately, observed fraud or abuse.
June 18, 2020
Facilitates project meetings with respect to the preparation and distribution of materials and final meeting minutes, as well as the coordination of participants.
June 25, 2020
Performs other duties as assigned by management.
July 19, 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.
July 28, 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.
August 03, 2020
Sets up and maintains Study Oversight Files in compliance with ICH GCP and SOPs as per the Project Manager instructions.
September 19, 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.
September 23, 2020
Provides supervision and coordination of all regulatory activities, workflow and regulatory staff.
October 05, 2020