DO YOU HAVE A PASSION FOR ENSURING THE HIGHEST ETHICAL STANDARDS IN HUMAN RESEARCH PROTECTION? ARE YOU EXCITED TO SUPPORT THE GOVERNMENT AND CLINICAL RESEARCHERS IN ENSURING SAFE AND EFFECTIVE RESEARCH PROTOCOLS?

Ripple Effect is looking for a Human Research Protection – Lead Analyst who holds a Top-Secret clearance and has regulatory and oversight experience in biomedical human research protection to support our client’s mission. In this role you will provide programmatic and task management support for the client’s compliance assurance program. Additionally, you will be a subject matter expert in Human Research Protection regulations, policies, and guidelines. You will serve as an information resource for the government and investigators 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.

MINIMUM EDUCATION AND EXPERIENCE

• MA/MS in the sciences, health policy, law, or information technology (IT)
• 10 years of relevant professional experience

BASIC REQUIREMENTS

• Current TS/SCI clearance
• Experience in the management and oversight of human subjects research ethics including knowledge of IRBs and privacy protection regulations.
• Expertise in applying laws, regulations, policies, procedures, and guidelines governing human research protection.
• Experience reviewing and making determinations of exempt, expedited, or full board review on human research protocols.
• Expertise to provide reviews of all types of research involving human research, human data, and biospecimens to ensure compliance with all applicable regulatory requirements and to delineate deficiencies and areas of noncompliance.
• Experience with or ability to assist in the development of policies and procedures based upon Federal, state, local and other laws, policies, and guidelines.
• Ability to analyze extremely complex problems and recommend, monitor, and execute best practice solutions to executive level management.
• Ability to prioritize among multiple projects in a fast-paced, deadline-driven environment, relying on your own resources and initiative.
• Demonstrated prior management experience, including training of junior analysts and organizing work assignments for the team.
  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 THAT SET YOU APART

• Relevant certifications, e.g., CIP, SOCRA, etc.
• Experience in either serving on or for the administration of an IRB or other ethical committee.
• Experience as a government contractor, supporting biomedical or health research programs within the DHS or other federal systems.
• Experience in compliance monitoring and/or auditing within the research enterprise.
• Available to travel nationally.
  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!

• Program Management and Administration: Support the development of the policies, structures, and processes necessary to sustain the work of the human research protections group. Support Department of Homeland Security (DHS) program management meetings and maintain communications with compliance offices in other departments and agencies as well as external regulatory entities.
• Information Management: Collect, analyze, track, store, and archive compliance program information through a database, shared drive, etc. Support the development and maintenance of compliance review database(s).
• Program Compliance: Plan and execute post-approval compliance activities, prepare compliance assessments, and record compliance activities. Inform stakeholders of applicable compliance issues and concerns. Provide guidance and recommend actions to resolve deficiencies and achieve compliance.
• Training & Outreach: Develop processes, facilitate events, and provide instructional support to establish and maintain awareness of human research protections compliance requirements.
• Policy Support: Support DHS policy development, including support for DHS in interagency and international meetings, preparation of briefing materials, data calls related to research compliance, and alerts, substantive analysis, and recommendations to address current issues. Maintain ongoing awareness of emerging trends in compliance as they relate to human research protection to inform policy support activities.