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Job Title


Regulatory Specialist - Human/Animal Subjects


Company : Watermark Risk Management International, LLC


Location : Lorton, VA


Created : 2020-05-30


Job Type : Full Time


Job Description

Watermark Risk Management is seeking a qualified Regulatory Specialist to provide Advisory and Assistance Services (A&AS) to support the Research Oversight Board (ROB) at the Defense Threat Reduction Agency (DTRA), Chemical and Biological Technologies Department. The successful candidate will provide A&AS support in the area of regulatory program support for a science and technology portfolio of projects that counter chemical and biological threats. This work is located in Lorton, VA. In this role you will... + Provide A&AS support to the Program Manager and Executive Secretary of the ROB, including registration, focused reviews, and technical assistance of DTRA funded new proposals and projects involving Human Subjects and Animal Use research + Monitor active and pending research studies to ensure compliance with annual review requirements, as well as identify and track DTRA personnel for compliance training + Compile and maintain regulatory documentation database and systems, analyze requirements for compliance, and prepare and maintain electronic files and folders + Oversee and manage the regulatory aspects of ongoing projects + Assess project issues and develop resolutions to meet regulations for project progress, intervention, and problem solving with project managers, line managers, and clients + Work with the DTRA Science and Tech Managers (STMs) and support staff to ensure compliance + Act as interface between study STMs and the DoD Animal Care and Use Review Office (ACURO) and the Human Research Protections Office (HRPO) at the Office of Research Protections (ORP) at the U.S. Army Medical Research and Development Command (USAMRDC) + Perform reviews of ACURO and HRPO approval turn-around-times + Liaison for DTRA STMs and PMs, project team and line management, with other DoD Components involved in Human Subjects and Animal Use research + Run ROB database queries and draft the quarterly ROB meeting minutes, slides, and documents to support the Executive Secretary during meetings + Participate in monthly coordination meeting w/ USAMRDC + Represent DTRA in the monthly DoD Animal Use Working Group (DAUWG) meeting, when the Program Manager or Executive Secretary are unable to attend + Assist with developing and tracking budgets and spend plans + Assist with tracking project expenditures, supporting the development of funding award documentation and development/maintenance of program review materials + Provide technical and logistical support to the client and be prepared to provide insight for internal taskers + Provide assistance with acquisition/contracting strategy for CBRN projects and programs + Maintain regular, clear, professional communication and relationships with team members, customers, and stakeholders, including contractors, subcontractors, grantees, consultants, etc. in the CBD community. Position Requirements: + Bachelor of Science plus 6 years or MS/MBA plus 4 years of experience related to human subjects and animal research protections, regulations, policies and programs + Active Secret security clearance + High-level proficiency with Microsoft Office programs; ability to quickly learn new IT systems and software; + Detail-focused, initiative, excellent communication and time management skills Desired Qualifications: + Certified IRB Professional (CIP) + PMP Certification from PMI + Knowledge of the DoD Chemical and Biological Defense Program (CBDP) and DoD acquisition policies + Prior experience coordinating and reporting other compliance functions such as Dual-Use Research of Concern (DURC) and Chemical and Biological Warfare Convention; + Three (3) years of project management and/or acquisition experience in Science and Technology or Research and Development, Testing and Evaluation. Clearance Required: DoD Secret Clearance with the ability to obtain Top Secret. Watermark Risk Management International, LLC is an Equal Opportunity and Affirmative Action Employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors.