To manage and optimize the clinical research infrastructure necessary for bringing novel/personalized cell and gene therapies to patients.
- Support the translation of first-in-human investigational cell and gene therapy products from the bench to bedside.
- Manage/accelerate the clinical trial development and new study activation pathways.
- Establish internal and external collaborative partnerships.
- Establish/maintain the infrastructure required to standardize and optimize clinical trial development and execution; and ensure ongoing oversight/compliance.
- Develop/refine standardized processes, procedures, and templates/tools to align with the changing regulatory landscape and new scientific innovation.
- Ensure generation of high-quality, reliable and statistically sound clinical data that can be used for reporting, publication, endpoint analysis and further product development.
- Identify/implement new technology/systems required to enhance clinical research operations.
- Manage the clinical trial development and study activation pathway
- Establish and maintain core document templates
- Facilitate new protocol and other core document development
- Develop and implement protocol/core document amendments
- Overall project implementation
- Establish the required infrastructure for executing new clinical trials
- Work with collaborative partners to manage study operations/study conduct
- Site Management: Establish/maintain project timelines, develop/perform study training, develop/maintain operational manuals, DSMB coordination/management, ensure timely data collection/reporting, etc.
- Document Management: Establish and maintain the Sponsor Trial Master File (TMF)
- Database development and ongoing maintenance activities
- Perform data management review/cleaning
- Ensure overall data completeness and quality/integrity
- Facilitate data reporting/archiving
- Amy Marshall, MPH – Director
- Avery L. Gaymon, MS H.Ed – Project Management Team Lead
- Samantha Hower, BS- Data Management Team Supervisor
- Lauren Boylan, BS - Sr. Data Management Operations Specialist
- Emily Dowd, BA- Sr. Clinical and Project Development Lead
- Matthew Ferrara, MS Ed- Sr. Clinical Research Project Manager
- Megan Four, BS - Sr. Clinical Research Project Manager
- Renee Jurek, MRA – Clinical Data Manager
- Ming Li, MS – Sr. Database Engineer
- Hoang Nguyen, BS – Database Programmer
- Anathalia Ortiz, BA- Clinical Data Manager
- Pooja Patel, MRA - Sr. Clinical Research Project Manager
- Justina Rosario, BA - Clinical Development Project Manager
- Nina Sizova, BS- Clinical Data Manager
- Carly Stein, BS - Sr. Clinical Research Project Manager
- Tam Tran, MS - Clinical Data Manager
- Ellie Paul, BSE- Sr. Clinical Research Project Manager
- Amanda Kotch, BS- Clinical Data Coordinator