Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included
Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review. Ensures timely submission of protocol documents for review by appropriate age.
Develops IRB submission packets for protocols, including writing of abstract, submission of standard forms and drafting of informed consent forms.
Maintains regulatory essential files on submitted and approved studies. Reviews all protocol revisions and amendments.
Amends consent forms if needed and follows established guidelines to determine if amendments requires IRB review distributes all amendments and IRB approved informed consent forms to relevant university protocol holders
Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements Provides regulatory updates and guidance to investigators and research staff of new or changed regulations
Research involving registration of patients, scanning and filing study consents, collecting patient data, for the clinical research trials in Radiation Oncology Department.
Obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements
Educates patients and families of purpose, goals, and processes of research study
Collection, processing, transporting of select biological samples for research trials.
Other duties as assigned.
Minimum Requirements:
Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
2 years experience in research or administrative capacity working on research projects; knowledge of research regulations, guidelines and compliance issues required.
Experience developing informed consent documents and preparing regulatory documents desired.
Experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred.
Function: Research Administration
Sub Function: Research Compliance
Career Band : Individual Contributor - Specialized
