Ripple Effect
Human Subjects Protection Program Manager
Ripple Effect, Frederick, Maryland, United States, 21701
Program Manager And Senior Human Subjects Protection Scientist
Do you have a passion for ensuring the highest ethical standards in human subjects research? Do you have demonstrated experience in program management within the biomedical research field, particularly involving regulatory compliance and oversight of research activities? Ripple Effect is looking for a Program Manager (PM) and Senior Human Subjects Protection Scientist with significant regulatory and oversight experience in biomedical human subjects research to support USAMRDC's Office of Human Research Oversight (OHRO). In this role you will hold dual responsibilities as a PM (estimated 80% level of effort) of a 26-member team while also maintaining (estimated 20% level of effort) a small portfolio of protocol reviews. As the PM, you will triage protocols, establish workload for your teams, have primary accountability for the team's deliverables and serve as central point of contact (POC) for OHRO leadership. You will be a subject matter expert in Human Subjects Protection and serve as an information resource for the government and investigator's submitting protocols for review. You should have the experience and expertise to review any submission type. If this position sounds of interest, there's a place for you here at Ripple Effect! We offer a diverse and engaging work environment, with a multitude of incentives and flexible work options that work for you and your lifestyle. General Information: Job Code: SHR-RA-05M Location: Frederick, MD Employee Type: Exempt, Full-Time Regular Telework: Hybrid (2-3 days per week in-office) Travel Required: None Clearance: NACI Manager: Yes Citizenship: Not required, but must be eligible to work in the United States without sponsorship Number of Openings: 1 Salary Range: $119,316
$128,000 Responsibilities: Initial Administrative Review: Review all types and risk levels of protocol submissions to determine their submission category. Conduct timely comprehensive initial reviews of proposal packages to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC's human subjects protection regulatory and cadaver use requirements. Delineate deficiencies, areas of noncompliance, and make recommendations regarding regulatory and ethical issues. Formulate and recommend potential solutions to complex problems that would bring protocols in compliance with regulatory requirements. Human Subjects Protection Policies and Procedures Development Support: Facilitate tracking of updates to regulations, policies and SOPs in dedicated MS Teams channels. Stay current with regulations and lead policy development by assigning and reviewing draft policies developed by the team. Ensure compliance with current regulations. Inform OHRO stakeholders of changes and updates relevant to DoD conducted and -supported research. Human Subjects Protection Education and Training: Conduct routine review and update of all internal orientation and training materials to ensure they reflect current regulatory requirements related to the protection of human subjects in research and cadaver use. Lead a quarterly team meeting to develop education resources and schedules. Use updated and approved materials to train OHRO reviewers and collect feedback on effectiveness of training materials in providing education on human subjects protection regulations and OHRO requirements. Monitor and sign-off on completion of training modules by team members. Quality Assurance: Actively oversee, manage and update protocol files in assigned portfolio and in the information management systems used to track information related to protocol review. Enter protocol-related information into automated information management systems and keep protocol status and event information complete and up to date. Enforce QC and assurance assessments of deliverables before submission to the government. Analyze workload management and review throughput data reports. Performance Improvement: Lead monthly retrospectives to review caseloads, quality and throughput metrics and to document lessons learned. Lead in performance improvement activities in specific working groups to improve and streamline the protocol review and approval processes and provide support for formulating and writing standard operating procedures and work instructions. Analyze team workload, operations, and review turnaround times. Lead process improvement when delays or quality issues are identified. Team management and reporting: Develop team workload projections and create backup plans. Responsible for submission of all deliverables to OHRO leadership such as monthly reports, project plans and NDAs. Serve as POC for government contracts officer and OHRO leadership. Manage and oversee the individual review team leaders, subcontractor staff and consultants.
Do you have a passion for ensuring the highest ethical standards in human subjects research? Do you have demonstrated experience in program management within the biomedical research field, particularly involving regulatory compliance and oversight of research activities? Ripple Effect is looking for a Program Manager (PM) and Senior Human Subjects Protection Scientist with significant regulatory and oversight experience in biomedical human subjects research to support USAMRDC's Office of Human Research Oversight (OHRO). In this role you will hold dual responsibilities as a PM (estimated 80% level of effort) of a 26-member team while also maintaining (estimated 20% level of effort) a small portfolio of protocol reviews. As the PM, you will triage protocols, establish workload for your teams, have primary accountability for the team's deliverables and serve as central point of contact (POC) for OHRO leadership. You will be a subject matter expert in Human Subjects Protection and serve as an information resource for the government and investigator's submitting protocols for review. You should have the experience and expertise to review any submission type. If this position sounds of interest, there's a place for you here at Ripple Effect! We offer a diverse and engaging work environment, with a multitude of incentives and flexible work options that work for you and your lifestyle. General Information: Job Code: SHR-RA-05M Location: Frederick, MD Employee Type: Exempt, Full-Time Regular Telework: Hybrid (2-3 days per week in-office) Travel Required: None Clearance: NACI Manager: Yes Citizenship: Not required, but must be eligible to work in the United States without sponsorship Number of Openings: 1 Salary Range: $119,316
$128,000 Responsibilities: Initial Administrative Review: Review all types and risk levels of protocol submissions to determine their submission category. Conduct timely comprehensive initial reviews of proposal packages to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC's human subjects protection regulatory and cadaver use requirements. Delineate deficiencies, areas of noncompliance, and make recommendations regarding regulatory and ethical issues. Formulate and recommend potential solutions to complex problems that would bring protocols in compliance with regulatory requirements. Human Subjects Protection Policies and Procedures Development Support: Facilitate tracking of updates to regulations, policies and SOPs in dedicated MS Teams channels. Stay current with regulations and lead policy development by assigning and reviewing draft policies developed by the team. Ensure compliance with current regulations. Inform OHRO stakeholders of changes and updates relevant to DoD conducted and -supported research. Human Subjects Protection Education and Training: Conduct routine review and update of all internal orientation and training materials to ensure they reflect current regulatory requirements related to the protection of human subjects in research and cadaver use. Lead a quarterly team meeting to develop education resources and schedules. Use updated and approved materials to train OHRO reviewers and collect feedback on effectiveness of training materials in providing education on human subjects protection regulations and OHRO requirements. Monitor and sign-off on completion of training modules by team members. Quality Assurance: Actively oversee, manage and update protocol files in assigned portfolio and in the information management systems used to track information related to protocol review. Enter protocol-related information into automated information management systems and keep protocol status and event information complete and up to date. Enforce QC and assurance assessments of deliverables before submission to the government. Analyze workload management and review throughput data reports. Performance Improvement: Lead monthly retrospectives to review caseloads, quality and throughput metrics and to document lessons learned. Lead in performance improvement activities in specific working groups to improve and streamline the protocol review and approval processes and provide support for formulating and writing standard operating procedures and work instructions. Analyze team workload, operations, and review turnaround times. Lead process improvement when delays or quality issues are identified. Team management and reporting: Develop team workload projections and create backup plans. Responsible for submission of all deliverables to OHRO leadership such as monthly reports, project plans and NDAs. Serve as POC for government contracts officer and OHRO leadership. Manage and oversee the individual review team leaders, subcontractor staff and consultants.