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Functional Subject Matter Expert - 1172793 with Security Clearance at Computer Technologies Consultants, Inc. (CTC)

Functional Subject Matter Expert - 1172793 with Security Clearance

Computer Technologies Consultants, Inc. (CTC) Washington, DC (Onsite) Full-Time
Computer Technologies Consultants (CTC) is seeking a Functional Subject Matter Expert - Human Research Protection to support our clients' team in the Washington, DC area. This position does require 1-2 meetings per week at the customer site. With offices in Washington DC and San Diego, CA, CTC is a leading technology company providing lifecycle IT, data analytics, cloud managed hosting services, agile software development, DevOps, Test Automation, Cyber Security, and infrastructure solutions. Additionally, we provide Professional Talent Acquisition Services as we proudly support the unique needs of U.S. Defense, Intelligence, and Federal Civilian agencies as well as Fortune 1000 companies. Why Should You Be Interested ? •Hybrid work schedule •Direct hire full-time position •Competitive base salary and comprehensive benefits •Mid-size company with room for growth Position Title : Functional Subject Matter Expert - Human Research Protection Position Location : This position is currently remote. Daily Responsibilities : •Serves as a top-level technical or functional expert supporting one or more clients and unlimited user groups. •Performs 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 •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) : •A minimum of 2-3 years of research and regulatory experience. •A minimum of 2-3 years of human subjects' protection and IRB experience. Required Degree/Certifications : •Bachelor's Degree (Master's Degree preferred) •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. •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. •Must know DoDI 3216.02 •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 Computer Technologies Consultants, Inc. is an Equal Opportunity Employer that provides employment opportunities for all qualified applicants without regard to race, color, religion, gender identity and/or expression, sexual orientation, age, mental or sensory differing abilities, protected veteran status, sex, national origin, or any other characteristic protected by applicable law. Computer Technologies Consultants, Inc. is devoted to diversity, equity, and inclusion.

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