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Job Descriptions: Position is contingent upon contract award Knowesis Inc. is currently looking for a Proposal Compliance Administrator to support the efforts of the Office of Human Research Protection - U.S. Army Medical Research and Development Command (USAMRDC). Duties and responsibilities may include, but are not limited to:
Provide timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.
Provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRDC. The HSPS III should have the expertise to provide reviews of all types of research supported by the USAMRDC, including, but not limited to, research involving human subjects, cadavers, human data, and biospecimens. The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance.
Provide recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the HRPO Approval Authority. The HSPS III will provide regulatory-based written initial reviews of protocols using standardized checklists.
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 and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to HRPO approval.
Provide human subjects protection regulatory consultation on selected proposals and pre-reviews of draft protocols as tasked by the Program Manager.
Conduct pre-reviews of projects submitted to the HRPO for determination of the applicability of the human subjects protection regulations and complete administrative review actions for protocols in post-approval oversight.
Interpret and apply federal human subjects protection requirements and make regulatory review recommendations for any HRPO administrative review action required, from initial submission through lifecycle oversight to study closure.
Provide accurate information, assistance and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the HRPO’s shared computer drive to facilitate review of future actions by team members.
Required Experience:Education Bachelor’s Degree in a scientific or engineering disciplined required, Master’s preferred Qualifications
5-8 years of related experience in scientific research, analysis and/or engineering.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred but not essential
Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight (essential).
Working knowledge of ethical principles related to participation of humans in research.
Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices.
Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRDC human subjects protection regulations, policies and guidelines.
Demonstrated ability to use all components of Microsoft Office and to write clear, precise, detailed, comprehensive and grammatically correct memos and technical reports.
Ability to become proficient in the use of an electronic document management system and Oracle-based protocol information management system.
Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.
Government Security Clearance:Must possess an active Public Trust or higher. Work Location:Client site in Fort Detrick at Frederick, MD. Keyword: Initial Administrative Review of Proposal and Protocol SubmissionsBenefitsAbout KnowesisFounded in 2007, Knowesis Inc. has been providing data driven decisions and solutions to federal healthcare clients from day one. Our core capabilities include analytics and information management, planning and operations, and communication and engagement strategies. Knowesis’ highly qualified, customer-focused professionals are committed to providing information and advice to enable client success through holistic, thorough, thoughtful, and aligned approaches. Our clients leverage these capabilities to support data driven decisions for their key business functions. Knowesis is dedicated to earning the loyalty of clients and staff through work ethic, collaboration, and humility. Our intent is to be a positive impact to our clients, team, and community. Knowesis is Service Disabled Veteran Owned (SDVO) (CVE certified) and Small Disadvantaged Business (SBA certified 8a) with offices in San Antonio, Texas and Fairfax, Virginia. We offer a highly competitive compensation and benefits package inclusive of medical, dental, and paid time off.For more information about working with Knowesis, please visit our website at http://www.knowesis-inc.com. Knowesis is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. Knowesis will consider all qualified applicants for employment without regard to race, color, religious creed, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, Knowesis will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.From: Knowesis Inc.
