Senior Human Subjects Protection Scientist

Seize your opportunity to make a personal impact as a Senior Human Subjects Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO) at Defense Health Agency Research & Development (DHA R&D). The ORRC OHRO ensures that DHA-conducted, contracted, sponsored, supported, or managed research—and U.S. Army Medical Command investigations—involving human subjects, human anatomical substances, or animals complies with Federal, DoD, and international regulatory requirements.

Responsibilities

• Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, DoD, FDA, state, host nation, and DHA R&D human subjects protection requirements.
• Review research protocols already approved by the local Institutional Review Board (IRB); identify deficiencies and areas of regulatory noncompliance, and make recommendations to the OHRO Federal Approval Authority regarding regulatory and ethical issues in OHRO submissions.
• Collaborate with investigators to update or revise materials, bringing protocols into compliance for OHRO approval.
• Manage a portfolio of protocols for initial review, including determinations of:
  • Not research
  • Research not involving human subjects
  • Exempt research
  • Non-exempt research
  • Protocols utilizing cadavers or cadaveric specimens
• Provide accurate, professional, and timely information, assistance, and documents to customers and OHRO Federal personnel.
• Actively manage the assigned protocol portfolio, including data entry and use of OHRO-specific information management systems to track review activities.
• Assist in developing policies, procedures, guidelines, and other materials to ensure compliance with current regulations and update stakeholders on human subjects protection and regulatory compliance.
• Support the development of local procedures and guidance for the OHRO and DHA R&D in human subjects protection.
• Contribute to the development and implementation of effective mechanisms to communicate and interpret regulations, policies, and guidelines.
• Assist in developing and implementing internal OHRO operating procedures and review guidelines as requested.
• Foster regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff.
• Provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements.
• Acquire and retain knowledge of current Federal, DoD, FDA, Army, state, host nation, and DHA regulatory requirements related to human subjects protection and cadaver use; apply this knowledge during OHRO reviews.
• Interact with colleagues, consultants, investigators, research directors, supervisors, and other U.S. Army personnel to gather or disseminate information, attend meetings and conference calls, and provide education on human subjects protection regulations and OHRO requirements.
• Participate in performance improvement activities, including working groups to streamline protocol review and approval processes, and provide input for OHRO standard operating procedures and work instructions.

Requirements

• Bachelor’s Degree in a scientific or related discipline.
• 3+ years of related human subjects protection experience (5+ years preferred).
• Knowledge of Federal regulations governing the protection of human research subjects, including the Common Rule and FDA regulations.
• Working knowledge of ethical principles related to human participation in research.
• Working knowledge of scientific research concepts and terminology to conduct detailed analyses of research protocols.
• Ability to apply DoD and DHA R&D human subjects protection regulations, policies, and guidelines after training.
• Proficiency with Microsoft Office Suite.
• Excellent organizational skills, meticulous attention to detail, and a professional, businesslike manner.
• Ability to track multiple tasks, manage review actions, and demonstrate strong critical thinking and problem-solving skills.
• Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical practices.
• U.S. citizenship required.
• Clearable for a NACI (T1) security investigation.

Skills

• Human Subjects Research
• IRB Protocol and Submission
• Research Protocols
• Ability to become proficient in electronic document management systems.

Schedule

• Hybrid schedule: 2 days onsite at Ft Detrick (Frederick, Maryland) and the remainder remote.
• Core hours: 9 AM to 3 PM (flexible scheduling around core hours).
• Scheduled weekly hours: 40.
• Travel required: 10-25%.

Pay

The likely salary range for this position is $85,093 – $101,200. Salary will be set based on experience, geographic location, and possibly contractual requirements.

Benefits

• Comprehensive medical, dental, and vision plan options, some with Health Savings Accounts.
• 401(k) plan with pre- and post-tax contribution options and company match.
• Paid time off, including vacation, sick, personal time, holidays, parental leave, military leave, bereavement, and jury duty leave.
• Short- and long-term disability benefits, life insurance, accidental death and dismemberment, personal accident, critical illness, and business travel and accident insurance.
• Flexible work weeks where possible to encourage work/life balance.