Human Subjects Protection Scientist

Do you have a passion for ensuring the highest ethical standards in human subjects research? Are you excited to support the government and clinical researchers in ensuring safe and effective research protocols?

Ripple Effect is looking for multiple Human Subjects Protection Scientists with regulatory and oversight experience in biomedical human subjects research to support USAMRDC's Office of Human Research Oversight (OHRO). In this role you will serve as the initial protocol reviewer, and work in a team of reviewers. You will be a subject matter expert in Human Subjects Protection and 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.

General Information

• Job Code: SHR-RA-03
• 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
• Citizenship: Not required, but must be eligible to work in the United States without sponsorship
• Number of Openings: 7
• Salary Range: $82,858.43 - $95,287.20 (how we pay and promote)

Responsibilities

• Pre- and Initial Protocol Reviews: Conduct pre- and initial protocol reviews of projects submitted to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and human subjects protection regulatory and cadaver use requirements. Formulate and recommend potential solutions to complex problems that would bring protocols in compliance with laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use.
• Compliance Oversight & Consultation: Interpret and apply federal human subjects protection requirements and make regulatory review recommendations for any administrative review action required, from initial submission through lifecycle oversight to study closure. Identification and assessment of noncompliance when the research is conducted prior to approval. Responsively engage in email and telephone communication with the Principal Investigator, the Approval Authority, and key study personnel to address questions, concerns, and outstanding issues.
• Human Subjects Protection Policies and Procedures Development Support: Assist the team in developing policies, procedures, guidelines, and other materials to ensure compliance with changes to current regulations. Stay current with regulations, provide input on changes and help draft new or updated policies and procedures to ensure compliance and to inform OHRO stakeholders of changes and updates relevant to DoD conducted and -supported research.
• Performance Improvement. Participate 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 and provide dashboard updates to team leader. Help with process improvement when delays or quality issues are identified.

Requirements

Minimum Education and Experience

• Bachelor's degree in life science, biomedical, or related field
• 8 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, relying on your own resources and initiative.
• Must work effectively in a team environment.

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

• Master's degree in a related field
• Relevant certifications, e.g., CIP, SOCRA, etc.
• CITI training in accordance with local IRB policy
• Experience in either serving on or the administration of an IRB
• Experience as a government contractor, 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.