BAI's Research and Regulatory Compliance Division assists U.S. government science and technology organizations in overseeing their cutting-edge research and development (R&D) programs. The Division's scientific, engineering, and regulatory professionals work closely with federal program managers and extramural partners to ensure that their critical defense and homeland security R&D efforts are carried out safely, securely, and in compliance with all applicable regulatory and policy frameworks. Regulatory areas of expertise include human subjects research protections, animal care and use in research, laboratory biosafety and biosecurity, biorisk management, arms control, and dual-use research of concern.
As a key member of a new team within this Division, BAI's Human Research Protections Analyst will support the Research Protections Division of a Department of Defense (DoD) research organization with a unique portfolio of innovative programs in areas such as human factors engineering, bioengineered systems, and warfighter performance and protection.
As BAI's Human Research Protections Analyst, your responsibilities will include:
Developing, refining, and managing project management tools for an agency-wide human research protections program;-
Reviewing and assessing agency commands, laboratories, and extramural collaborators for compliance with Federal-level and agency-specific requirements for the protection of human research subjects;
Preparing and reviewing Federal-wide and DoD Assurance packages for agency components and sponsored entities with human subjects research programs;
Carrying out evaluations of potential or unanticipated problems involving risks to participants in agency-sponsored research projects, to include issues involving research noncompliance or misconduct, and developing reports and recommendations for corrective actions;
Conducting post-approval reviews of human research protocol submissions, to include evaluating Institutional Review Board (IRB) proceedings and meeting minutes, to monitor compliance and support continual quality improvement efforts;
Developing and updating processes, materials, and databases for the agency's human research protections program and its compliance and oversight functions, and assisting with the generation of reports, metrics, presentations, and other program deliverables; and
Providing subject matter expertise and consultation on complex program-level and project-specific initiatives for ensuring the protection of human subjects in all agency-sponsored research activities
This job might be for you if:
You have at least three years of professional experience in human research protections and are excited about expanding your experience and accelerating your career path in the field.
You have a strong understanding of federal regulatory and policy frameworks and compliance processes for human research protections, along with a general understanding of DoD- and/or DoN-specific policies and processes.
You are looking to apply your unique expertise toward the advancement and oversight of innovative extramural science and technology R&D programs.
You have some experience reviewing medical and non-clinical protocols and compliance documentation for research activities involving human subjects.
You thrive in a fast-paced, customer-focused environment, and you enjoy taking on new challenges.
You communicate clearly. You write well and speak eloquently. You're able to explain detailed scientific, technical, and regulatory information to a layperson.
To qualify for this position, you must have the ability to obtain a Security clearance (existing clearance strongly preferred), as well as a Bachelor's degree and at least three years of professional experience in human research protections. Experience supporting a federal agency's human research protections program is highly desired, and direct experience with DoD/DoN programs is strongly preferred. You should also be proficient with MS Office programs (Excel, Word, PowerPoint, Outlook).
It would be nice if you had:
Experience with DoD/DoN human research protections programs.
Academic, research, and/or professional experience in the biological sciences, neuroscience, physiology, psychology, or sociology.
In-depth understanding of regulatory and policy requirements and compliance considerations for both biomedical and non-clinical research involving human subjects.
Previous involvement or interactions with investigators, IRBs, and other stakeholders for federally funded human subjects research programs.
BAI, Inc. is an equal opportunity employer.
Celebrating 20 years of successful Business, BAI - one of Inc. Magazine's 5,000 Fastest-Growing Private Companies In America - has built a strong reputation upon the excellence of our carefully selected employees and the comprehensive, innovative solutions we provide to our government clients. BAI employees are customer-focused, cleared professionals with the education and experience to support a wide spectrum of science and technology, management, analytical, administrative, security, and IT/cybersecurity mission areas. From managing research and education programs in homeland security-related fields to reviewing critical technology acquisition initiatives for compliance with international arms control agreements, our forward-thinking employees are continually positioned to make a positive impact on our country's safety, security, and resilience, now and in the future.