Human Subjects Protection Scientist

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

NACI (T1)

Job Family:

Science and Research

Job Qualifications:

Skills:

Ethical Standards, FDA Regulations, Human Subjects Research, Research Protocols

Certifications:

None

Experience:

1 + years of related experience

US Citizenship Required:

Yes

Job Description:

Seize your opportunity to make a personal impact as a Human Subjects Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Institutional Review Board Office (IRBO) at Defense Health Agency Research & Development (DHA R&D).

The ORRC IRBO is responsible for ensuring that investigations involving human subjects, and human anatomical substances are conducted in accordance with Federal, DoD, and international regulatory requirements.

HOW YOU WILL MAKE AN IMPACT:

• Provide administrative support to the IRB Office; this includes monitoring a shared Outlook mailbox, communicating with investigators, logging in and setting up protocol review files, email communication with IRB Office staff, etc.
• Provide support for and during IRB Meetings; this includes scheduling meetings, sending read-ahead packages to IRB members, sharing reviews/documentation with other IRB members, etc.
• Provide administrative support for drafting IRB meeting minutes with a potential for taking this task on entirely in the future.
• Attend all IRB meetings.
• Assist the Government to develop and maintain policies, procedures, guidelines, and other materials to ensure compliance with current regulations
• Participate in performance improvement activities to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing standard operating procedures and work instructions for administrative support tasks and protocol review activities
• Interact with colleagues, consultants, investigators, research directors, supervisors, IRB members, other US Army and DHA personnel, etc., to gather or disseminate information or to provide assistance related to IRB reviewed protocols

WHAT YOU’LL NEED TO SUCCEED:

• Education: Bachelor’s Degree in a scientific, or related discipline
• Required Experience: 1-2 years of related human subjects’ protection experience
• Required Technical Skills: Knowledge of the Federal regulations governing the protection of human research subjects, including familiarity with 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 of all research protocols submitted for IRB review.
• 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; thrive in a small team environment as a positive, engaged, and supportive team player; exhibit excellent written and oral communication skills with many different internal and external customers; remain flexible to address shifting priorities; willingness to learn new tasks; excellent time-management skills. 
• Preferred Skills: Ability to become proficient in the use of multiple electronic document management system (eIRB, Electronic Grants System, etc.)
• 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
• 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 co