General Dynamics Information Technology is a global technology and professional services company that delivers consulting, technology, and mission services to every major agency across the U.S. government. They are seeking a Human Subjects Protection Scientist to support the Office of Research and Regulatory Compliance, ensuring that investigations involving human subjects are conducted in accordance with regulatory requirements.

Responsibilities

• 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

Skills

• Bachelor's Degree in a scientific, or related discipline
• 1-2 years of related human subjects' protection experience
• 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
• Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices
• 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
• US citizenship required
• Clearable for a NACI (T1) security investigation
• Ability to become proficient in the use of multiple electronic document management system (eIRB, Electronic Grants System, etc.)

Benefits

• Comprehensive benefits and wellness packages
• 401K with company match
• Competitive pay and paid time off
• 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.
• Flex work weeks where possible
• Paid parental leave
• Paid military leave
• Paid bereavement leave
• Paid jury duty leave
• Short and long-term disability benefits
• Life insurance
• Accidental death and dismemberment insurance
• Personal accident insurance
• Critical illness insurance
• Business travel and accident insurance

Company Overview