Functional Subject Matter Expert - Human Research Protection

Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well look no further! Experience this family oriented company who takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with Systems Plus you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of and work in collaborative, dynamic, and high-tempo environments.


Our employees are our most valued asset and we invest in our people because we are in it for the long term. We are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities world-wide.


Systems Plus is the company for you! Experience the difference and let’s talk about your future at Systems Plus today.

Position Title Functional Subject Matter Expert - Human Research Protection
Position Type Full Time
Position Location Falls Church, VA
Tracking Code 00960
Daily Responsibilities
  • Serves as a top-level technical or functional expert supporting one or more clients and unlimited user groups.
  • rforms highly specialized technical tasks associated with cutting-edge technologies.
  • Works with user groups to solve business problems with available technology including hardware, software, databases, and peripherals.
  • Applies expert functional knowledge and experience to significant business projects or processes.
  • Applies expert knowledge of human subject protection laws and regulations and supports the Human Protection Regulatory Compliance program for the DHA J9 HRPP.
  • Assists with development of policy and procedures based upon Federal laws, policies, and guidelines, (32CFR219 National Defense, Protection of Human Subjects, 45CFR46 Department of Health and Human Services, Protection of Human Subjects).
  • Assists with compliance efforts.
  • Provide expert guidance regarding ethical foundations, DoD and other Federal regulations, regulatory compliance, Good Clinical Practice (GCP) and clinical trials standards, other research standards for all aspects of human subject research regardless of discipline.
  • Develops a business process for the electronic filing system for documentation including IRB reviews and determinations, pre-reviews and regulatory reviews.
  • Formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects’ research, including regulatory coordination (work with other regulatory offices to coordinate human subjects’ protection reviews) as required.
  • Ensures constructive communications among the IRB, human subjects and Institutional Official as a means of maintaining a high level of awareness regarding the ethical conduct of research, and safeguarding of the rights and welfare of subjects.
  • Educates the institution’s staff to maintain a culture of compliance with all Department of Defense (DoD) regulations and institutional policies and procedures relevant to the protection of human subjects
  • Ensures the implementation of appropriate oversight mechanisms to ensure compliance with all applicable regulations and the determinations of the IRB
  • Ensures the implementation of appropriate oversight mechanisms to ensure compliance with all applicable regulations and the determinations of the IRB
  • Provide a working knowledge of HIPAA rules and regulations and reports any HIPAA violations to Privacy Officer
  • Modifies and maintains a database to track the lifecycle of human subject research, including IRB reviews and pre-reviews, determinations and regulatory reviews.
  • Maintains electronic filing system HRPP.
  • Calculates, compiles and submits metrics for HRPP performance measures.
  • Prepares HRPP briefing slides.
  • Interfaces with research sites on an ongoing basis. Facilitates information flow and acts as a liaison between research review boards and Federal and Contractor Principal Investigators, research staff, and administrative staff.
  • Obtains and files electronic documents for determinations, pre-reviews, IRB reviews and regulatory reviews for research.
  • Conducts pre-reviews for research involving human subjects and makes preliminary determinations and forwards recommendations to the Human Protections Administrator (HPA).
  • Conducts regulatory reviews for the post-IRB approval lifecycle management of research including new studies, continuing reviews, amendments, unanticipated problems involving risks to subjects or others, serious adverse events, continuing noncompliance, serious noncompliance, research suspensions, research terminations, protocol deviations, investigations and audits of human subject research, and study closures. Submits written findings for each assigned Human Research Protection Official review to the HPA.
  • Ensures prompt reporting of noncompliance as applicable and seeks corrective action.
  • Assess work products for accuracy, timeliness, and adherence to DoD requirements, automated data information system entries and use of the shared computer drive.
  • Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).
  • Strategize with the Federal personnel to improve current processes by developing work instructions, standard operating procedures and standardized forms.
  • Conduct administrative and HRPO reviews for human subject research.
  • Provides support to ensure compliance of research programs with applicable federal, state and local regulations and DoD requirements for human subject research.
  • Shall assist the HPA with oversight of research involving recombinant DNA
  • Level of effort tracking and documenting these tasks shall be part of the Monthly Progress Report (MPR).
Required: Years of Experience (min)
  • 10-15 years of related experience in scientific research, analysis, and/or engineering
  • A minimum of 5 years of DOD research and regulatory experience in the Military Health System’s Laboratories.
  • A minimum of 3 years of research and regulatory experience.
  • A minimum of 3 years of human subjects’ protection and IRB experience.
Required: Degree
  • Bachelor’s degree (strong preference for health or science)
  • Must have attained or are eligible to attain certification as a Certified IRB Professional (CIP), Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA)
Required: Experience
  • Expert level knowledge of human subjects’ protection regulations, policies, and guidelines.
  • Expert level knowledge of the Department of Defense (DoDs) Directives and Instructions including 32 CFR 219 (Common Rule), DoDI 3216.02, and all applicable Federal statutes, regulations.
  • Must have attained or are eligible to attain certification as a Certified IRB Professional (CIP), Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA).
  • Prior experience within the DoD/VA systems of care strongly preferred.
  • Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed.
  • Have the ability to analyze extremely complex problems and recommend, monitor and execute best practice solutions to executive level management.
  • Good written and oral communication skills, along with the ability to work well in teams.
  • Must be available to travel locally, regionally and nationally.
Required: Clearance
  • Agency Clearance

About Systems Plus


Systems Plus is headquartered in Rockville, MD with over 2 decades of experience providing Global Enterprise Management, Technology, Engineering and Professional services and solutions across Defense and Federal Civilian government sectors.


From Discovery to Delivery, Systems Plus brings a greater measure of confidence, commitment and value to our clients. With various Defense and Federal contracts across the United States, Europe and Pacific/Asia, we are driving innovation and excellence within the Special Operations Forces Components and Commands, Defense Health Agency, United States Air Force, United States Marine Corps, National Institute of Standards and Technology, House of Representatives and more.


Through our diverse portfolio of clients and capabilities we power vision and insight—discover what’s possible with a Small Business that thinks BIG!

Interested individuals should email their resume with salary expectations and with a cover letter to careers@sysplus.com .