PCI, a Global Communities Partner, is seeking a consultant to write technical guidance content for an organization-wide Research Guidance Packet. This consultant will be responsible for reviewing and validating the proposed Table of Contents for the Research Guidance Packet, reviewing existing internal and external guidance and regulations relevant to the Packet content, generating written content for the key sections of the Packet, organizing content into a single, comprehensive document that will serve as the organization’s research guide, and providing the Packet to PCI in a final version (in English). The primary purpose of this Research Guidance Packet will be to provide comprehensive guidance across the organization that includes, but is not limited to, research regulations and organizational processes, protection of human subjects, and designing and implementing ethical and rigorous research.
Specifically, the Research Guidance Content Writer Consultant will:
- Produce an initial draft that includes content for all designated sections for review and feedback by the Senior Technical Advisor, Research Committee, and additional PCI staff as necessary.
- Three main sections are expected, each with sub-sections:
- Research regulations and organizational processes: sub-sections include overview of Common Rule, the role of IRB, submission and approval processes, etc.
- Protection of human subjects: sub-sections include identifying risks, data management for confidentiality, special considerations for vulnerable populations, informed consent, etc.
- Designing and implementing ethical, rigorous research: sub-sections include importance of rigor, guidance on developing research questions, design and data collection tools, data management for quality, budgeting for research, engaging research partners, etc.
Total length is TBD but anticipate about 60 pages with new and existing content.
- Produce a final comprehensive research packet submitted to the PCI Research Committee.