Req ID: RQ169202Type of Requisition: RegularClearance Level Must Be Able to Obtain: NonePublic Trust/Other Required: NACI (T1)Job Family: ScientistsSkills:Human Subjects Protections,IRB,Regulatory RequirementsExperience:2 + years of related experienceUS Citizenship Required:YesJob Description:Seize your opportunity to make a personal impact as a Human Subjects Protection Scientist (HSP) to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at the US Army Medical Research and Development Command (USAMRDC).The OHARO OHRO is responsible for ensuring that USAMRDC conducts, contracts, sponsors, supports or manages research, and U.S. Army Medical Command investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.HOW YOU WILL MAKE AN IMPACT:
Provide real-time oversight of USAMRMC-supported research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection regulatory requirements
Provide regulatory-based written review and a comprehensive evaluation of protocol life cycle actions (continuing review, amendments/modifications, closures, reports of serious or continuing non compliance, reports of unanticipated problems involving risk to subjects or others, protocol suspension, protocol termination, etc.) using standardized checklists and guidance materials
Delineate deficiencies and areas of noncompliance and makes recommendations to the OHRO federal AAs regarding regulatory and ethical issues in OHRO post-approval submissions
Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner
This will require active management of the assigned protocol portfolio; this includes data entry activities and use of OHRO specific and updating the protocol files and the information management systems used to track information and activities related to protocol review
Support the OHRO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols. Employee shall provide regulatory-based written review of OHRO reportable events; includes preparing, planning, conducting, and reporting on compliance inspections of research for which OHRO has oversight
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 USAMRDC
Assist in the development of local procedures and guidance for the OHRO and the USAMRDC 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 USAMRDC 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
WHAT YOU’LL NEED TO SUCCEED:
Education: Bachelor’s Degree in a scientific, or related discipline
Required Experience: 2+ years of direct human subjects protection experience
Required Technical Skills: Must possess a working 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 HQ USAMRDC 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, Army and USAMRDC human subjects protection regulations, policies and guidelines; Proficiency with Microsoft Office Suite; Ability to become proficient in the use of an electronic document management and review system
Security Clearance: Clearable for a NACI (T1) security investigation
Required Skills and Abilities: Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success; Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices
Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 1 day onsite and remainder remote); Staff are expected to be accessible during core hours of 9AM to 3PM, but have flexibility to set their schedule around those core hours.
US citizenship required
GDIT IS YOUR PLACE:
401K with company match
Comprehensive health and wellness packages
Internal mobility team dedicated to helping you own your career
Professional growth opportunities including paid education and certifications
Cutting-edge technology you can learn from
Rest and recharge with paid vacation and holidays
#GDITPriority#MilitaryHealthGDITJobs#GDITPublicHealthJobs#GDITHealthWe are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation’s most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
