- Oversee RTSL system for ensuring compliance with relevant United States and local country laws and standard operating procedures related to protecting human subjects in research activities
- Develop internal processes and policies to ensure RTSL compliance including:
- Monitor for changes in applicable laws and regulations to ensure HSR SOPs remain up to date
- Convene and lead an internal Research Subcommittee
- Draft and update the HSR SOPs as needed, in consultation with and for the approval of the Research Subcommittee
- Develop and conduct training of staff and consultants to ensure compliance with HSR process
- Track staff compliance with HSR training requirements
- Establish and maintain a relationship with a preferred US IRB(s)
- Provide program staff and management with support and guidance when applying RTSL HSR Policy and SOPs and when making submissions to IRBs
- Evaluate use of IRBs other than the preferred US IRB(s) that are proposed by RTSL programs to review HSR projects
- Maintain “Approved IRB” lists
- Conduct periodic reviews of program activities to ensure compliance with RTSL SOPs
- Investigate and escalate instances of deaths and other serious adverse events among study participants and HSR non-compliance as and when required under the HSR SOPs and applicable laws
- Maintain in good standing RTSL’s permissions/regulatory approvals w/r/t HSR, including the organization’s Federalwide Assurance (FWA) and relevant State certifications
- Maintain records of IRB determinations and reviews and of instances of non-compliance and make periodic reports to the Research Subcommittee
- Collaborate with senior leadership to develop a learning culture focused on operational research, documenting learnings and sharing findings
- Provide advice and support to technical teams in developing research projects
- Establish a network and liaise with RTSL research partner organizations and technical consultants providing support for research design, evaluation, and interpretation
- Coordinate capacity building activities related to improving conceptualizing, drafting, submitting and publishing peer review manuscripts through internal and external trainings, mentoring or other approaches
- Develop internal SOP for review and approval of peer review manuscripts
- Establish mechanisms for sharing relevant research and evidence related to RTSL work
- Coordinate submissions to conferences
- Ensure accurate acknowledgement of intellectual and financial contributions of staff, partners, and donor organizations
- Coordinate on research dissemination plan with internal and external communications and advocacy experts
Required Qualifications:
Experience
- At least 7 years prior experience in one or more of the following roles: IRB administration or human protections administrator
Education and Degree
- BA or BS degree in the biological / health sciences
- Master’s or JD preferred
Skills and Abilities
- Ability to analyze, interpret and communicate complex governmental regulations and guidelines to non-experts, both verbally and in writing
- Detailed working knowledge of human subjects research international guidelines (Declaration of Helsinki; Belmont Report) and the U.S. laws and regulations set forth in the Common Rule (45 CFR part 46), including OHRP regulations
- Self-motivated with exceptional organizational skills
- Excellent oral and written communication skills
- Strong understanding of research methodologies
- Advanced Microsoft Office skills including Word, Excel, and PowerPoint
Professional Certification
- Successful completion of CITI Human Subjects Research training and the Certified IRB Professional (CIP) exam
We believe our programs are strengthened when they are developed and supported by individuals with diverse life experiences, whose understanding of social and cultural issues can help make our work and workforce more inclusive. We encourage applications from and provide equal employment opportunities to all qualified applicants without regard to race, color, religion, gender, gender identity or expression, ancestry, sexual orientation, national origin, age, disability, marital status, or status as a veteran. Resolve to Save Lives complies with all applicable EEO laws.
Resolve to Save Lives offers excellent benefits. In the US, this includes health, dental, vision and life insurances, short-term and long-term disability coverage, the support of an Employee Assistance Program, a 403(b)retirement plan, a professional development fund, generous vacation, personal health leave, parental/adoption leave, and much more.
Resolve to Save Lives requires all employees regardless of location or job function to be fully vaccinated against COVID-19, including a booster. Resolve to Save Lives complies with federal, state, and local laws with regard to accommodations related to this policy.
Job Type: Full-time
Pay: $98,000.00 – $110,000.00 per year
Benefits:
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: Remote