Req ID: RQ202557
Type of Requisition: Regular
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACI (T1)
Job Family: Scientists
Skills:
FDA Regulations,Human Subjects Research,IRB Protocol
Experience:
5 + years of related experience
US Citizenship Required:
Yes
Job Description:
Seize your opportunity to make a personal impact as a Senior Human Subjects Protection Scientist supporting the Office of Human Research Oversight (OHARO) who is responsible for ensuring that the United States Army Medical Research and Development Command (USAMRDC) conducts, contracts, sponsors, supports or manages research, and USAMRDC investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.
GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career. At GDIT, people are our differentiator.
HOW YOU WILL MAKE AN IMPACT:
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), Department of the Army, state, host nation, and MRDC 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
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. *This will require active management of 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 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: 5+ years of related human subjects protection experience
Required Technical Skills: Working knowledge of the Federal regulations governing the protection of human research subjects; 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 system and Oracle based protocol information management system
Security Clearance Level : Not applicable, but must be clearable for a public trust (NACI-T1)
Required Skills and Abilities: Must be able to work well in teams and be able to communicate effectively with all levels of staff
Location: Hybrid position located at Ft Detrick (Frederick) - must be able to work onsite at least 1 day per week
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
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The likely salary range for this position is $83,429 - $97,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We 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 50 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.
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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
