Clinical Trials Office

Clinical operations provide disease working group support, study initiation oversight, patient screening, eligibility confirmation and enrollment, protocol activity management, study data collection, clinical research sample processing and preparation, and collaboration with all patient care teams to ensure study parameters are met.

Regulatory services provide new trial feasibility review management, study activation coordination, FDA IND and IDE application preparation and submission, and overall management of regulatory activities through the lifecycle of a study.

The research finance team assists with both pre- and post-award activities including coverage analysis, OnCore study calendar creation, study budgets preparation and negotiation, contract review and execution in coordination with the VCU Department of Sponsored Programs, clinical research charge review, investigators and ancillary service payment, and monthly account reconciliation. This team also supports the development of budgets and/or cost estimates for IIT concepts or Letters of Intent.

This team provides expertise in new concept development, protocol writing, electronic case report form creation and overall study management of both single- and multi-site IITs through close out and manuscript development.

QAC activities include independent monitoring and auditing of Massey IITs per the risk assignment level outlined in Massey's NCI-approved Data and Safety Monitoring Plan.

The Affiliate Network team provides operational support, training and education, progress reporting and compliance monitoring for sites participating under Massey’s MU-NCORP.

This unit ensures all clinical research reporting requirements are met such as ClinicalTrials.gov and NCI Clinical Trials Reporting Program.