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.
January 25, 2023
Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for GIMO clinical trials.
January 29, 2023
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.
March 17, 2023
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.
April 06, 2023
Maintains records of existing IAAs, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
April 27, 2023
Participates in and may provide oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.
April 28, 2023
Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
May 16, 2023
