• Provide an overview of the UCI-Fred Hutch Collaboration (including major operational/administrative and research functions as part of Global Oncology and as part of the Collaboration)
• Understanding of how a research or related project works within the Collaboration
• Discuss potential research or related projects, including:
  • Research questions
  • Goals and objectives 
  • Purpose or significance 
  • Schedule or budget considerations
  • Staffing in Uganda
• Communication channels 

If you are interested in working with our Collaboration, would like to learn more, or discuss potential projects, please contact Stuart Tenney, Senior Director, Finance and Operations.

• Manage and administer all aspects of sponsored funding, in coordination with all Core Research Services*
• In collaboration with Principal Investigators, prepare and submit grant and contract applications to sponsors, ensuring compliance with sponsor regulations
• Plan and prepare the budget and related financial and administrative portions of the grant and contract applications
• Coordinate with Fred Hutch Office of Sponsored Research (OSR) on sponsor compliance for grant and contract applications
• Perform budget-to-actual reporting of sponsored funding sources
• Ensure personnel effort and salary are reported monthly by the appropriate person(s)

*Please note: Research Administration will lead coordination with each Core Service team. 

Stuart Tenney, Senior Director, Finance & Operations

Mary Jane Chua, Research Administration Manager 

• Supports development of protocols tailored to UCI-Fred Hutch Collaboration standards
• Produces consent forms tailored to UCI-Fred Hutch Collaboration standards
• Prepares and reviews Fred Hutch and University of Washington Institutional Review Boards (IRB) and Uganda Research and Ethics  Committees (REC) submissions and correspondences
• Provides regulatory consultation and support to investigators and study staff throughout the lifecycle of a study
• Coordinates and documents internal regulatory processes and submissions
• Provides study startup support
• Maintains credentials (e.g., CVs, medical licensures, a delegation of authority logs) in accordance with Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines
• Provides internal monitoring and audit readiness guidance
• Produces standard operating procedures and study-specific procedures
• Staff training on different aspects of research, e.g. Good Clinical Practice (GCP), Human Subjects Protection (HSP), Informed Consent Procedures, documentation, Adverse Events, Serious Adverse Events, study protocols
• Standard Operating Procedures (SOP) and Study-Specific Procedure (SSP) writing

Contacts

Noreen Muwanguzi,  Regulatory Affairs Manager, HCRI-Ug  

Jessica Rowden, Senior Regulatory Coordinator, Clinical Research Support (CRS), Fred Hutchinson Cancer Center

• Study start-up
  
• Study management
• Study conduct
• Study monitoring
• Data support
• Study closure
• Management of importation and maintenance of study drugs/medications
• Data and Safety Monitoring Board (DSMB) coordination (note: the team does not have their own DSMB, but can provide guidance on the process, document writing, contracts, etc.)
• Contract writing with different labs and personnel

Contact

Jacqueline Asea, Clinical Trials Director, HCRI-Uganda 

• Molecular diagnostics
• Histopathology
• Specimen processing
• Genomic analysis
• Biorepository
• Biosafety level 2 laboratory
• SARS-CoV-2 testing

Visit the Laboratory & Facilities page to learn more about our laboratory capabilities. 

Contact

Andrea Towlerton, Laboratory Director, HCRI-Uganda 

•  Case report form (CRF) design: provide input on CRF content based on past study experience and convert rough drafts into polished PDF forms using FrameMaker software.
• Database design-build: work with investigators and the study team to implement CRFs on REDCap to create a secure, web-accessible study database that includes skip-patterns and data-entry validation.
• Data entry and quality control: enter data collected on paper CRFs or directly from study source documents, e.g., lab reports into the study REDCap database. Lab data can also be imported directly into the database to avoid keying large data sets. The Data Team relies on double data entry, either entirely by two independent data coordinators or shared between a data coordinator and study coordinator. Double entries are routinely reconciled, and queries are addressed in collaboration with study staff and investigators.
• Reports: Data managers can routinely provide reports that are designed collaboratively with the study team. Reports can be accessed through a secure internet portal using R Shiny apps, sourcing data from the REDCap Application Programming Interface (API), allowing for dynamic updates as data are collected and cleaned.
• Statistical Programming and Analysis: Data managers can construct data sets for analysis and perform tabulations, figures, and statistical analysis in Stata or R, based on investigator specifications and the study Statistical Analysis Plan. Ad hoc reports and tables can be created as needed, and identification of participants for specimen pull-lists can be generated in collaboration with the laboratory team.

Fees

The Data Team members are supported directly by funded grant budgets (rather than “fee for service”). Thus, a set level of average annual salary support for data coordinator(s) and a data manager is agreed upon for each project. Please contact our Research Administrators to learn more.

If you have questions about any data management and analysis capabilities, please contact our team. 

Contacts

Kelvin Mubiru, Data Manager, HCRI-Uganda