Human Research Protection Program Specialist

Aalis Management Consulting is an 8(a) certified, Service-Disabled Veteran-Owned Small Business (SDVOSB) and Economically Disadvantaged Woman Owned Small Business (EDWOSB) driven by the same principles that guide our armed forces. Founded by a US Army veteran, we take pride in our core values: excellence in reputation, commitment, candor, teamwork, and dependability.

Title: Human Research Protection Program Specialist

Client: DoD

Location: Silver Spring, MD ( Onsite and Telework)

Clearance: Secret

The Contractor shall develop, implement, and maintain compliance and training activities for the Human Research Protection Program. The objective of this task is to provide guidance and counsel on incorporating compliance-related activities into the day- to-day operations of the Human Research Protection Program. The work isto ensure regulatory and policy updates are disseminated to investigators and research staff in a timely manner, perform ongoing monitoring of all areas of research compliance, and act decisively on issues of potential non-compliance.

This position will oversee the education and training process forresearch and non-research employees regarding compliance-related activities. Duties will encompass three major areas of regulatory compliance relevant to the NMRC Research and Development Program. These areas are 1) protection of human subjects in research, 2) biosafety, and 3) conflict of interest.The incumbent must possess a broad knowledge ofthe interrelated Federal and State laws/regulations governing each of these four areas. The contractor ensures that records contain all documentation required by the Bureau of Medicine and Surgery (BUMED), Food and Drug Administration (FDA), and the Department of Health and Human Services (DHHS) regulations. He/she coordinates the preparation for surveys and site visits

Qualifications:

• Require Bachelor's degree in biomedical sciences, research, related field.
• Requires three years of investigative and auditing process for Research Compliance by providing auditing support for larger studies, scribing services for compliance interviews, and reviewing reports, as well as managing emails, notifications, follow ups, and general communication
• Ability to work efficiently in a complex regulatory environment with minimal supervision is critical
• Knowledge of federal and state regulations governing participation of human subject in research.
• Knowledgeable and experience using electronic media, including Microsoft Office software (Word, Excel, Power-Point, etc.)
• Excellent interpersonal, organizational, and time-management skills
• Thrive in a team-oriented, collaborative, results-driven workplace