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• Assisting with development of other protocol tools• Assisting with study-specific procedures (SSP) or site SOP development• Organizing and conducting protocol trainings• Conducting mock protocol visits• Conducting protocol refresher trainings, as needed• Contributing to CRF development• Site development, site assessment and readiness activities• Developing clinical research training curriculum (GCP, QMP, Good Documentation Practice, Regulatory Filing Structure, etc.)• Managing and conducting protocol activation with sites and Sponsor participation

• 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• Data collection & entry into study-specific MS Access database• Participant appointment scheduling and coordination• MS Access database coding and maintenance• MS Excel database maintenance• Study-specific phlebotomy and specimen processing• Surgical tissue procurement and processing (fresh, frozen, and NBF preparation)• Tissue sample, blood sample, and slide storage management• Archived specimen and file storage and relocation management• Hired as Research Project Coordinator - Clinical, promoted to Specialist 5/12

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; spreadsheet and database design and maintenance; data entry; statistical analysis; literature searches for presentations and publications.

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.