Senior Scientist

Senior Scientist and Science Technician Group 1

Minimum Qualifications Summary

Certification & Education Required

• Master's Arts/Science Degree

Experience Required

• Extensive and demonstrated human research protections experience; master's degree or higher degree preferred, in any discipline but preferably in STEM, health policy, law, or information technology (IT) with demonstrated human research protections experience.
• At minimum, be eligible to take the Certified IRB Professional (CIP) exam.
• Experience applying the following: The Common Rule and other regulations relevant to the protection of human subjects in research, DHS and other Federal regulations, regulatory compliance, Good Clinical Practice (GCP) and clinical trials standards, and other research standards for all aspects of human subjects' research.
• Demonstrated knowledge of HRPP/IRB/REC administration and management.
• Demonstrated knowledge of various types of research portfolio oversight and management methods and systems.
• Ability to analyze extremely complex problems and recommend, monitor, and execute best practice solutions to executive level management.
• Experience with or ability to assist in the development of a regulatory framework based upon Federal, state, local and other laws, and guidelines.
• Ability to meet with and present to senior officials.
• Be able to read, write, speak, and understand English.

Job Objective

Conduct research dealing with the understanding of human diseases and the improvement of human health. Engage in clinical investigation, research and development, or other related activities. Includes physicians, dentists, public health specialists, pharmacologists, and medical pathologists who primarily conduct research. Practitioners who primarily provide medical or dental care or dispense drugs are included in "Health Diagnosing and Treating Practitioners.

Responsibilities

• Provide support to the Government in developing or revising DHS directives, instructions, procedures, guidance's, and other information to ensure research compliance for activities conducted, supported or funded by DHS
• Determine documentation requirements for regulatory and compliance assurance reviews.
• Manage the collection, analysis, and archiving of documentation for regulatory and compliance assurance reviews and record-keeping in a centralized database
• Conduct systematic reviews of DHS-sponsored activities for compliance with Federal laws, regulations, and guidelines in accordance with applicable DHS directives, instructions, procedures, and other guidance
• Coordinate with appropriate Federal agencies for joint inspections, including, as applicable, under interagency agreements and arrangements.
• Provide timely support and recommendations, as needed, for departmental review and oversight of activities that could raise compliance concerns.

Work Location

Washington DC

About Lukos

Lukos has been delivering professional services to the Federal Government for 15 years. We help a variety of federal agencies in areas such as national security, homeland security, international development, training, analytics, healthcare, and other professional services. Since our founding, we have grown to support all military services and multiple federal civilian agencies.

About Our Name: Lukos is ancient Greek for "wolf". The characteristics of the wolf match our approach to national security. The wolf is known for cunning, aggression, patience, and teamwork. An individual wolf is smart, strong, and resilient, but the true strength of wolves is their ability to work together as a wolfpack. Kipling said it best in The Law of the Jungle.

"For the strength of the pack is the wolf, and the strength of the wolf is the pack."

At Lukos we take care of our pack by offering full time employees competitive benefits to include: medical, dental, vision, 401(k), life insurance, short and long term disability coverage, paid time off and Federal holidays.

Lukos is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or national origin.