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 our client's mission. In this role you will serve as the initial protocol reviewer, and lead teams of reviewers within the office. 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 are a diverse, progressive, and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle.

• Job Code: SHR-RA-03, 04T, 05M
• Location: Positions in the MD, VA, and DC area
• Employee Type: Exempt, Full-Time Regular
  (Ask our recruiters about flexible work arrangements)
• Telework: Hybrid (2-3 days per week in-office)
• Travel: May require occasional CONUS and/or OCONUS travel for site visits
• Security Clearance: NACI and up to Secret (depending on position)
• Citizenship: Not required, but must be eligible to work in the United States without sponsorship
• Number of Openings: Multiple
• Salary Range: $82,858 to $137,213 (how we pay and promote)

• Pre- and Initial Proposal Reviews: Conduct pre-reviews of projects submitted for applicability of the human subjects protection regulations. Provide timely review of proposal submissions (and associated research protocols, consent forms, IRB approvals, and recruitment materials) submitted to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and human subjects protection regulatory and cadaver use requirements
• Detailed Research Protocol Reviews: Provide regulatory-based written initial reviews and consultation of protocols using standardized checklists and expertise. 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.
• Administrative Support: Provide accurate information, assistance, and documents to customers. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of working materials to facilitate review of future actions by team members. Complete administrative review actions for protocols in post-approval oversight.
• Training & Documentation: Develop and update SoPs and checklists to support quality management. Develop and conduct training and resource materials to facilitate knowledge of most recent regulations and overall success of the human research protections program

• BA/BS in a life science, biomedical, or related field
• 6 years of relevant professional experience

• 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.

• 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 servicing 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!

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

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.

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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 race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, political affiliation, or Veteran status. 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.