Senior Human Subjects Protection Scientist

General Dynamics Information Technology • Fort Detrick, MD

1d • Hybrid

About The Position

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 is responsible for ensuring that DHA conducted, contracted, sponsored, supported or managed research, and U.S. Army Medical Command investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, and international regulatory requirements.

Requirements

• Bachelor’s Degree in a scientific, or related discipline
• 3+ years of related human subjects’ protection experience
• Knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for DHA R&D review and oversight
• Working knowledge of ethical principles related to participation of humans in research
• Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review
• Following individual training and guidance, ability to become expert at applying DOD, and DHA R&D human subjects protection regulations, policies and guidelines
• Proficiency with Microsoft Office Suite
• Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices
• Possess excellent organizational skills and professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success
• Ability to track multiple tasks and review actions
• Excellent critical thinking and problem solving skills
• US citizenship required
• Clearable for a NACI (T1) security investigation

Nice To Haves

• 5 + years experience
• Ability to become proficient in the use of an electronic document management system

Responsibilities

• Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, Department of Defense (DoD), Food and Drug Administration (FDA), state, host nation, and DHA R&D human subjects protection requirements
• Review research protocols that have undergone review and approval by the local Institutional Review Board (IRB); the OHRO reviewer will delineate deficiencies and areas of regulatory noncompliance and make recommendations to the OHRO Federal Approval Authority (AAs) regarding regulatory and ethical issues in OHRO submissions.
• Work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval
• Reviewers will be assigned a portfolio of protocols for initial review; this includes determinations of not research, research not involving human subjects, exempt research, non-exempt research, and protocols utilizing cadavers/cadaveric specimens
• Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner
• Actively manage the assigned protocol portfolio; this includes data entry activities and use of OHRO specific information management systems to track information and activities related to protocol review
• Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the DHA R&D
• Assist in the development of local procedures and guidance for the OHRO and the DHA R&D in the area of human subjects’ protection
• Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines
• Assist in development and implementation of internal OHRO operating procedures and review guidelines as requested
• Foster regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff, and 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 the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during OHRO reviews of assigned projects
• Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and OHRO requirements
• Participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing OHRO standard operating procedures and work instructions

Benefits

• 401K with company match
• Variety of medical plan options
• Health Savings Accounts
• Dental plan options
• Vision plan
• Full flex work weeks where possible
• Variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave
• Short and long-term disability benefits
• Life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior