Human Subjects Protection Scientist

General Dynamics Information Technology•Fort Detrick, MD

13h•$64,230 - $72,450•Hybrid

About The Position

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.

Requirements

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
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
US citizenship required
Clearable for a NACI (T1) security investigation

Nice To Haves

Ability to become proficient in the use of multiple electronic document management system (eIRB, Electronic Grants System, etc.)

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