|Job Title||Study Coordinator, Regulatory Affairs and Training Coordinator (from Nov 2010)|
|Date of Scholarship||September - November 2010|
|Host Country||Seattle, Washington, USA|
|Scholarship||Responsible Conduct of International Research, University of Washington Internship, Fred Hutchinson Cancer Research Center|
INSTRUCTION IN ASPECTS OF RESEARCH MANAGEMENT AND IMPLEMENTATION
I attended a two week course at the University of Washington, The Responsible Conduct of International Research (RCIR), and a six week internship at the Fred Hutchinson Cancer Research Center (FHCRC). At the FHCRC I received training in four major areas; computer software packages, clinical research operations, regulatory affairs and leadership skills development.
The RCIR course developed my skills in proposal writing, grant application and review process, major aspects of project implementation (including protocol submissions to domestic and foreign regulatory bodies), quantitative and qualitative study designs, preparations of study instruments and budgets, grants management, data management and the preparation of presentations, abstracts, posters and manuscripts. In addition, the course gave me an opportunity to discuss the ethical dilemmas faced by international and domestic researchers such as ancillary care for health research in developing countries and research involving stored biological samples. Most importantly, I produced a research protocol, “Factors affecting adherence to cancer treatment and follow up at the Uganda Cancer Institute”. I view the development of this proposal as a very great achievement in my career and one that could be implemented if funded.
I improved my computer skills with courses that included; Columns and Tables in Microsoft Word, Simplifying Tasks in Microsoft Word, Introduction to Excel, Working with Functions in Excel, Data Analysis and Reporting, Microsoft Project and Working with Business Diagrams in Visio. These courses provided materials and knowledge that I am passing on to my colleagues.
Another part of my training targeted enhancing clinical research operations in preparation for clinical trials. I discussed training requirements for researchers, carrying out staff training needs assessments, internal communications, storage of regulatory and essential documents, building relationships with institutional review boards/ethics committees , community engagement, clinical trials pharmacy development, clinic quality management plans, data management at the study site, and adverse events in clinical research. Included was an orientation at an HIV Vaccine Trials Unit (HVTU).
The regulatory training focused on two major areas; ethical requirements/human subjects protection and production of quality data at the site. Topics included; the protocol development process, informed consent development, source documentation, Federal Wide Assurance (FWA), conflict of interest and financial management in research, filing documents, preparing for a monitoring visit, introduction to Genome Wide Associated Studies (GWAS) and confidentiality issues, specimen repositories, contents of regulatory binders, IRB/regulatory documentation of approvals and reviews of protocols and translated versions of consent forms.
In addition, I received training to improve my leadership skills which included; Dealing with Difficult People, Assertive Training and Giving Feedback, Conflict Management, and Advanced Meeting Facilitation.
This training was tailored to equip me with skills and knowledge necessary for my transition to a new role as Regulatory Affairs and Training Coordinator which I assumed on 1 November 2010. This scholarship was timely and apart from the exposure and cultural perspective, it was an opportunity to understand the standards of performance required of me and my collaborators in research.