Benefits:

Dental insurance

Health insurance

Paid time off

Overview

Senior Scientists with experience in of human diseases and human health

The Senior Scientists shall act as an alternate/deputy Program Manager (PM) during any absence of the Senior Manager/Program Manager.

Position Description

HUMAN RESEARCH PROTECTIONS COMPLIANCE

The candidate will 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.

Tasks for the project will include supporting a centralized, comprehensive assessment program for DHS research compliance and provide regulatory support in this area, to include for example:

a) Providing 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 (“DHS-sponsored”).

b) Facilitating the identification of DHS-sponsored activities subject to regulatory and compliance assurance reviews.

c) Determining documentation requirements for regulatory and compliance assurance reviews.

d) Managing the collection, analysis, and archiving of documentation for regulatory and compliance assurance reviews and record-keeping in a centralized database.

e) Conducting 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.

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.

Shall be able to read, write, speak, and understand English

Qualifications:

Master’s Arts/Science or Phd Degree 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