Human Subjects Protection Program Manager

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
  (Ask our recruiters about flexible work arrangements)
• 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 (how we pay and promote)

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.

Requirements

Minimum Education and Experience

• MS/MPH in a life science, biomedical, or related field
• 10 years of relevant professional experience

Basic Requirements

• Expertise in the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use.
• Experience in the management and oversight of human subjects research ethics including knowledge of IRBs and privacy protection regulations.
• Experience reviewing and making determinations of exempt, expedited, or full board review on human subjects research protocols.
• Expertise to provide reviews of all types of research including, but not limited to, research involving human subjects, cadavers, human data, and biospecimens to ensure compliance with all applicable regulatory requirements and to delineate deficiencies and areas of noncompliance.
• Ability to prioritize among multiple projects in a fast-paced, deadline-driven environment, and triage protocol review workloads.
• Experience as a Project or Program Manager and/or team leader.

To be successful at Ripple Effect, you must be able to pay attention to details, clearly communicate, work independently, and have an eagerness to learn. Learn more about what makes Ripple so great, check out our capabilities.

Skills And Qualifications That Set You Apart

• Relevant certifications, e.g., CIP, SOCRA, etc.
• CITI training in accordance with local IRB policy
• Experience in either servicing on or the administration of an IRB
• Experience as a PM on a government contract, supporting biomedical or health research programs within the DoD

If you don't have all of the skills above, don't be discouraged-no resume paints a complete picture of a person. There's a good chance you're more wonderful than you think, so please apply!

About Ripple Effect

Ripple Effect is an award-winning women-owned small business providing professional consulting and exceptional talent for federal, private, and non-profit clients. We deliver multi-disciplinary solutions across Communications & Outreach, Research & Evaluation, Program Management & Policy, Digital Transformation, and Technical & Scientific Support solutions with a focus on science, research, and healthcare domains.

Hiring Process Life at Ripple

Benefits

Ripple Effect rewards our employees for their contributions to our mission in many ways, from competitive pay and exceptional benefits to a range of work/life programs based on your employment classification and personalized preferences.

Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of to race, color, religion, sex, national origin, age (40 or older), disability, or genetic information. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process, please let us know by contacting our HR department at HR@rippleeffect.com or your recruiter. Eligibility for employment will be verified using E-verify.