Overall Position Summary and Objectives The client is researching liquid biopsies for multi-cancer early detection and is currently planning a large clinical utility trial. This type of research introduces multiple, complex human research participation issues: evaluation of potential harms, assessment of risks in the context of possible benefits (or lack of benefit), and representation of minority, underserved, under-insured and non-English speakers. The client requires a consultant with extensive experience in research ethics and human subject protection regulations related to study planning, tissue procurement, and research recruitment. The consultant must be familiar with conducting government-sponsored research in the Cancer Institute's research infrastructure.
Minimum Education: Master's
Certifications & Licenses :Diversity Equity and Inclusion Certification
Skills (Ranked By Priority)
- Non-Disclosure Agreement (NDA), CFR, FAR, GMP, ICH GCP, HIPAA, IRB, eCTD, CRIS, SOPs, PubMed, FAERS
- Human research subject protections
- Literature and database searches
- Subject recruitment/enrollment
Field of Study : Public Policy
DELIVERABLES
- Write ethics section for manuscript - Ad-Hoc
- Prepare or review slides for presentations to client or outside audiences - Ad-Hoc
- Provide written review comments of protocols, informed consent documents, and recruitment materials - Ad-Hoc
- Attend MCED planning meetings and provide written or verbal guidance on ethical issues - Ad-Hoc
Provides executive experience needed to conduct needs assessments and develop recommendations for improvements of current operations.
Provide analyses, evaluations, technical assessments, feedback and support in the planning and implementation of activities functional responsibility
Collaborates with other professionals to develop recommendations for current and future initiatives.
Provide advice on emerging issues affecting the Institutes research mandate functional responsibility
Advises management and staff on formulation of new strategies and sensitive or complicated issues.
Review plans for future programs based on draft and final forms description
Work with staff to develop policies for programs, including engagement, informed consent, enrollment, return of results, and sample governance 1
Works with staff to develop and implement new and proactive programs geared to specific audiences.
Provide input on complex inquiries
Conducts research and analysis to proactively address and respond to inquires on various policies and issues.
Lead and or attend and participate in working groups, meetings and conferences
Write and edit scientific technical products for a variety of audiences, including the scientific community functional responsibility
Coordinates and advances professional development and research done by others in areas where other mechanisms may not be optimal due to time constraints or other issues.
Review scientific papers, reports and manuscripts prepared by others, prior to submission