Senior Human Subjects Protection Scientist

Job Description 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. How You Will Make an Impact Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, 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); 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. Manage a portfolio of protocols for initial review, including 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, performing data entry activities and using OHRO specific information management systems to track information and activities related to protocol review. Assist the Government in developing policies, procedures, guidelines, and other materials to ensure compliance with current regulations and updating 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. Develop 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 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 U.S. 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, as required, force 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. What You’ll Need to Succeed Education: Bachelor’s Degree in a scientific, or related discipline. Experience: 3+ years of related human subjects’ protection experience. Technical Skills: Knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations; working knowledge of ethical principles related to participation of humans in research; working knowledge of scientific research concepts and terminology; 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. Attributes for Success: Ability to effectively communicate with researchers, research staff, and IRB members; possess excellent organizational skills, professional conduct, businesslike manner, meticulous attention to detail; ability to track multiple tasks and review actions; excellent critical thinking and problem solving skills. Preferred: 5+ years of experience; proficiency with an electronic document management system. Salary and Benefits Salary range: $85,093 - $101,200. The salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Benefits include medical, dental and vision plans (some with Health Savings Accounts), 401(k) plan with company match, paid time off 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. Full flex work weeks and a variety of paid time off plans are also available. Location and Schedule Location: Ft. Detrick (Frederick, Maryland) – Hybrid schedule (work 1 day onsite and remainder remote). Work Hours: Staff are expected to be accessible during core hours of 9AM to 3PM, but have flexibility to set their schedule around those core hours. Travel: 10–25%. Requirements U.S. citizenship required. Clearable for a NACI (T1) security investigation. Equal Opportunity Employer Equal Opportunity Employer. Individuals with Disabilities and Protected Veterans are encouraged to apply. Additional Information For more information about GDIT's Privacy Policy, click here: #J-18808-Ljbffr Dormont Manufacturing Co