Clinical Operations

Smilow
Smilow Center for Translational Research

The Clinical Operations Team is responsible for bringing Penn-Developed cell and gene therapy investigational products into the clinical trial setting.  In this role, the Clinical Operations Team will be involved from initial study/document development through study completion.  The team has significant experience in protocol development, project management, site management, data management, regulatory/compliance issues, and the operational requirements for executing complex exploratory, pilot, and Phase I and Phase II clinical trials.


The Clinical Operations Team is responsible for:

Clinical Development: Facilitating the development of clinical research protocols, consents, operational manuals, and other forms/documents required to conduct a clinical trial.
Project Management:  Overall project implementation; Establishing the required infrastructure for executing new clinical trials; Site Management; Managing study conduct, progress, deliverables, and vendor relationships.
Data Management: Facilitating the collection/analysis of clinical research data to ensure overall data quality/integrity; includes case report form development/maintenance and data cleaning/screening activities
Document Management: Development/maintenance of the Sponsor Trial Master File (official record of the clinical trial)