Steven Schech Email & Phone Number

Bethesda, MD

• Protocol development (writing, revising, etc.)
• Facilitation of regulatory review process over the lifetime of a protocol (initial submission, amendments, safety reporting, etc.)
• Mapping out regulatory and study implementation strategies
• Communicating with Sponsor and organizing kick-off meeting
• Preparing and monitoring study timeline (primarily start-up)
• Preparing and managing MOP development

• Study staff and medical student supervision and training
• Facilitation of regulatory review process via submissions to the institutional IRB (applications, amendments, annual renewals)
• NCI/NIH project management
• Working fund management
• Clinical research document development (protocols, ICFs, CRFs, eCRFs, etc.)
• Study participant screening, consenting and enrolling

Blood draw; specimen processing and storage; specimen shipping; petty cash distribution and fund maintenance; cognitive testing; IRB submissions (applications, amendments, annual renewals); study supplies procurement; participation in weekly diagnosis meetings; appointment scheduling; participant transportation arrangement; participant screening.

Administration of Woodcock-Johnson III Tests of Achievement to adolescents; administration of the Baltimore How I Feel (BHIF) mental assessment; administrative procedures; adolescent risk assessment; field representation for AIR.

Human participant consenting; olfactometer preparation for mock scanner & fMRI; E-prime task setup and execution; E-prime task debugging & re-writing; compensation management; data analysis; neuroimaging using Unix workstation; data presentation.

Human participant consenting/assenting; E-prime task setup and execution; compensation management; data analysis; confidential information handling using Clinical Data Warehouse (CDW); contacting & scheduling participants; data presentation.