Senior Human Subjects Protection Scientist

Public Trust: NACI (T1)

Requisition Type: Regular

Your Impact

Own your opportunity to be on the frontlines of health innovation. Deliver for America’s health agency missions and enhance lives for hundreds of millions every day.

Job Description

Seize your opportunity to make a personal impact as a Senior Human Su bjects 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.

• 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

• This position is tasked with reviewing 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. The reviewer will 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

• 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 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

WHAT YOU’LL NEED TO SUCCEED:

• Education: Bachelor’s Degree in a scientific, or related discipline
• Required Experience: 3+ years of related human subjects’ protection experience
• Required 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, 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
• Attributes for Success : 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

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

• Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 2 days 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

• US citizenship required

• Security Clearance: Clearable for a NACI (T1) security investigation

GDIT IS YOUR PLACE:

At GDIT, the mission is our purpose, and our people are at the center of everything we do.

• Growth: AI-powered career tool that identifies career steps and learning opportunities
• Support: An internal mobility team focused on helping you achieve your career goals
• Rewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time off
• Community: Award-winning culture of innovation and a military-friendly workplace

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Work Requirements

Years of Experience

5 + years of related experience

* may vary based on technical training, certification(s), or degree

Certification

Travel Required

10-25%

Citizenship

U.S. Citizenship Required