Description
-Participate in development of new intramural clinical research studies, both for solid tumors and hematology/oncology, reviewed all new protocols, supervised designing case report forms for the new protocols for the solid tumors and hematology/oncology. -Work with the multiple investigators on developing and implementing new intramural oncology protocols and supervised accomplishments with all protocols' requirements. -Work with the Food and Drug Administration (FDA) implementing new protocols, receiving exemptions reports for the Investigational New Drug (INDs) applications, prepared safety reports and annual protocols' progress reports to the FDA for the protocols holding Investigational New Drug (INDs). -Conduct internal and external audits and quality control of the data collection and protocols accomplishment for the phases I-III both solid tumors and hematology/oncology studies. Prepare the audit and safety reports for the Independent Data Monitoring Committee (DMC), IRBs (local and affiliated) and the FDA when applied. -Monitor for the safety all of the phase I protocols with the dose escalation treatment schemas. Supervised study suspension or closure out for the safety reasons. -Conduct study “start-up” and “close-out” meetings. -Interview and train new staff.