Research Protections Manager (Jr158)

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges.

PATH’s Office of Research Affairs (ORA) is seeking a Research Protections Manager. ORA supports PATH’s mission by ensuring that PATH’s research is scientifically and ethically sound; providing education to program staff to support research activities; managing institutional systems to support research oversight and compliance and providing strategic guidance to support best practices for research at PATH.

Responsibilities:

• Manage internal monitoring of PATH research to ensure compliance with PATH policies. Use monitoring findings and observations to make recommendations for education, training of PATH staff and to identify gaps in the Human Research Protection Program (HRPP).
• Conduct administrative reviews of PATH research and provide guidance to ensure compliance with PATH policies and procedures.
• Support development of internal IT systems (e.g., Salesforce) to manage and improve research workflows.
• Serve as member of PATH’s Research Determination Committee.
• Manage Investigator Conflict of Interest (CoI) processes, reviews, and reporting to ensure compliance with PATH policy and procedures, including requirements by the Public Health Service.
• Serve as the institutional contact for PATH in managing the external IRB oversight of PATH’s human subjects research (HSR).
• Support the Research Integrity Officer with Scientific Integrity processes and reviews.
• Support teams through consultations and guidance to understand and meet PATH research requirements and promote sound scientific and ethical research.
• Conduct benchmarking as needed to inform HRPP policies and practices.
• Provide guidance, based on expertise in research ethics and regulations, to institutional leaders, Office of Research Affairs and PATH research teams to inform decision-making, compliance management.
• Develop and draft new policies, procedures and guidance documents to support PATH’s Office of Research Affairs priorities, institutional needs and US regulations.
• Serve as main contact with federal officials (e.g., US Food and Drug Administration the Office of Human Research Protections, OHRP, the National Institutes of Health) for purposes of PATH’s HRPP institutional policies and procedures, clarification regarding regulatory requirements.
• Develop and run reports on PATH research to support institutional needs.
• Provide training and outreach to PATH staff to promote sound scientific and ethical research.
• Manage PATH’s internal research ethics committee, including communication with study teams, committee members, IRBNet processes, updates to federal authorities for IRB requirements (e.g., maintaining current FWA, IO, Committee Members, etc.); drafting reports to regulatory authorities.
• Serve as the Human Protections Administrator on PATH’s Federal wide Assurance (FWA) with the US government.

Required experience:

• Minimum of 10+ years of compliance management in Human Research Protection Programs, including: development and oversight of HRPP policies and processes, experience with IRB management; regulatory compliance; reporting; record management, advanced knowledge and expertise with US research regulations and requirements (FDA, HHS, NIH), experience with IRB oversight with external IRBs, experience managing investigator conflict of interest policies and oversight, and experience with scientific misconduct policies and oversight
• Excellent oral and written communication skills
• Proven ability to work in a dynamic and collaborative team environment
• Experience with oversight of non-US research and global research portfolios strongly preferred
• Must have legal authorization to work in the United States
• Master’s degree in public health or related health discipline
• Certified IRB Professional (CIP)
• Superior organization skills and attention to detail
• Expertise with public health research, including research determinations strongly preferred

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.

PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.