Human Research Protections Program Task Lead

Eagle Global Scientific, LLC is seeking an HRPP Task Lead to lead subject matter expert support for research integrity and misconduct (RIM) policy, education, inspections, and misconduct investigations.

The HRPP Task Lead owns the policy, investigation, and inspection work of the RIM program, which develops, interprets, and implements RIM policies to foster a culture of ethical research practices in research conducted or supported by the customer, and which ensures compliance with the Federal statutes, regulations, and agency directives and instructions related to RIM. The role interfaces on an ongoing basis with federal research sites, research review boards, Federal and Contractor Principal Investigators, research staff, and administrative staff, and coordinates with government personnel on investigation findings, policy revisions, inspections, and program metrics.

Essential Position Functions
• Conduct reviews of institutional and research facilities' RIM policies for compliance with RIM regulations, applying knowledge of RIM regulations and requirements.
• Interface with research sites on an ongoing basis to facilitate information flow, acting as a liaison between research review boards and Federal and Contractor Principal Investigators (PIs), research staff, and administrative staff.
• Conduct assigned research misconduct investigations under 45 CFR 689 and 42 CFR 93.
• Submit written findings for each assigned misconduct investigation to the government personnel within the program.
• Support the customer in conducting institutional inspections to monitor for compliance with RIM regulations, make recommendations for improvement, and attend site visits, which may require travel, upon request of the technical lead.
• Plan and conduct on-site inspections of Institutional RIM Programs; six (6) inspections, each involving one (1) or two (2) team members, are planned each year.
• Review and create draft revisions of SOPs and other guidance and policy documents.
• Revise and update the agency's RIM administrative instruction with applicable RIM regulations to encompass all types of research.
• Draft SOPs for processing allegations of misconduct for customer review and approval.
• Conduct reviews of RIM policy guidance, instructions and checklists and suggest changes to maintain compliance with Federal, agency, and local regulations and policies.
• Draft and develop a business process for the electronic portal for researchers to report potential research misconduct for Government review and approval.
• Provide support to ensure compliance of research programs with applicable federal, state, and local regulations and agency requirements for RIM.
• Prepare and offer quarterly training for institutional Research Integrity Officers (RIOs) and Decision Officials (DOs).
• Conduct monthly meetings and provide ongoing support for Institutional RIOs.
• Coordinate the workflow of RIM activities and regulatory oversight and review process.
• Support the establishment and efforts of the RIM committee.
• Generate reports for other federal agencies as necessary, each agency having its own requirements.
• Perform regular process and quality improvement/best practice analysis.
• Attend RIM investigation training (one week course) hosted by the Office of Research Integrity (ORI).
• Track progress and document requirements as part of the Monthly Progress Report.
• Other duties as assigned.

Candidate Requirements
• Master's degree.
• Six (6) plus years of experience working in a Human Research Protections Program (HRPP) or Institutional Review Board (IRB).
• Proficiency with interpreting research integrity and misconduct regulations including 45 Code of Federal Regulations (CFR) 689 and 42 CFR 93 to draft RIM policies and procedures and to perform research misconduct investigations.
• At least one (1) year of managerial experience.

Preferred Experience & Certifications

Experience or certifications with the following are a plus:
• Certification as a Certified IRB Professional (CIP).
• Completion of Office of Research Integrity (ORI) research misconduct investigation training.
• Experience conducting research misconduct inquiries or investigations, or comparable compliance or regulatory investigations.
• Experience conducting compliance audits, site assessment visits, or program inspections and writing findings with corrective action recommendations.
• Experience supporting a research integrity or human research protections program within a federal agency.
• Experience drafting or revising agency instructions and standard operating procedures for government review and approval.
• Experience preparing and delivering training to Research Integrity Officers, IRB members, or institutional officials.
• Experience managing deliverables and reporting on a federal services contract.

Benefits

Eagle Global Scientific, LLC offers a competitive benefits package that includes paid holidays, paid time off including sick and vacation leave, medical, dental and vision insurance, flexible spending accounts, short and long term disability, company paid life insurance, 401(k) with a company match and discretionary profit sharing and tuition reimbursement.