Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for GIMO clinical trials.
February 17, 2020
Reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
February 29, 2020
Collects and organizes materials for audit, including the regulatory binder, subject research record, case report forms, medical records, test article accountability documents, screening and enrollment logs.
April 07, 2020
Works with study sponsors and/or Clinical Research Organizations (CROs)) to develop budget documents that conform to both MD Anderson and Sponsor requirements.
April 19, 2020
Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with Federal, State, and local regulations.
April 28, 2020
Provide expert guidance to study team members to en sureparticipant care expenses have been set up correctly and that financ ialcharges/expensed route in a timely manner.
May 08, 2020
Maintains records of existing IAAs, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
June 10, 2020