Trial Design

Study Development

Coordination of protocol development
Budget development
Consent development/review
File the IND application with the FDA and annual IND reports
Provide operational input to the core study documents including the protocol, informed consent and eCRF, etc.
Executes contract with vendors
Enters the study into clinicaltrials.gov and updates the study as needed
Registers the study in pharma-specific report systems
Provides operational input into selection of external partners.
Prepares slides for the SIVs and conducts the SIVs with the PI

Establish trial master file for essential documents
Communicates the study status regularly and escalates unresolved issues
Provides updates on operational timelines
Ensures the maintenance, tracking and accuracy of operational data milestones
Reviews and manages variances between actual and forecast spending across the operational budget.
Communicates variances and action plan for resolution.
Review, approval and sign-off of study related invoices
Primary contact for affiliates to maintain oversight of performance, issues and resolution.
Provides operational information and/or reviews safety information/reports
Responds to protocol questions from sites, IRBs, external vendors etc.
Primary day to day contact for operational related activities where appropriate.
Orders drug supply and makes sure sites have adequate drug at their sites
Submit protocol deviation/violations to the PI for review
Submit trial safety events to the PI for review
Prepare monthly agenda/minutes for the SARC Clinical Trials Review Call
Follow up with sites to ensure the data is entered timely