Hyperion Biotechnology, Inc. has been providing services to federal government customers for over 15 years. Our customers receive comprehensive services to meet the specified requirements of their projects. With strong leadership and corporate infrastructure, Hyperion offers support and solutions to ensure the successful execution of our customers' programs.
Serve as the Compliance Specialist for the Department of the Navy Human Research Protection Program (DON HRPP)). The work involves application of knowledge and understanding of ethical foundations for human subject protection including understanding of the applicable laws and regulations and administrative organization of research activity.
Serve as a subject matter expert on regulations governing human research.
Serve as point-of-contact for assigned Commands and provide guidance and oversight, as needed.
Review and analysis of Institution HRPP Instructions, policies, and procedures
Conduct site inspections and assist visits with Commands with the purpose of assessing compliance and provided training related to human research protections. Prepare written reports to communicate findings.
Compliance review of protocol submissions, minutes, and assurances.
Education and Training
Coordinates the development and implementation of education and training program by developing courses, seminars, and instructional programs, for DON HRPP intramural performers.
Coordinates the development, and implementation of courses, seminars, and instructional programs, for DON HRPP staff employees to maintain DON HRPP staff core skills and competencies.
Assists in developing educational and information articles, for periodic newsletter focusing on what is happening in Navy research and the human research protections regulatory environment.
Provide an annual assessment of content on a DON-provided web-based training tool (currently CITI). Develop and conduct training related to trends identified during assist visit and site inspections
Provide recommendations on how to decrease misinterpretations and improve compliance.
Master's degree, with education, training, and experience in areas related to human subjects' protection. Please be able to explain your experience as a CRC in the context of human subjects' protection.
Experience working with human subjects protections regulations; Investigational Research Board. Experience as a Clinical Research Coordinator counts as meaningful experience.
Education, training and experience related to the application of 45 Code of Federal Regulations 46, Food and Drug Administration (FDA), and other federal human subjects protection regulatory requirements. Please list all training experience.
Advanced knowledge of regulatory environment pertaining to human subjects in research, as demonstrated by certification (e.g., CIP or eligibility to obtain CIP)
Advanced knowledge and understanding of ethical foundations for human subject protection.
Knowledge of training methodologies.
Knowledge of FDA and clinical trials standards, compliance and administration, and all core elements and standards for the responsible conduct of research.
Experience with planning and delivering training programs using technology as the primary delivery method.
Experience in team building, customer service, and continuous quality improvement.
Excellent communication and analytical skills.
Excellent writing skills.
Must be able to obtain a SECRET clearance.
Must be a U.S. citizen.
Understand and apply oral and/ written instructions. Communicate routine factual information.
Understand complex problems, opposing points of view on highly complex issues, collaborate and explore alternative solutions, and to negotiate and integrate different viewpoints.
Organize thoughts and ideas into understandable terminology. Must possess the ability to organize and prioritize the work schedules of themselves and others on a short and long term basis.
Reasoning and Decision Making
Member must possess the ability to make decisions that have moderate impact on the immediate work unit and monitor impact outside immediate work unit.
Communication Must possess the ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc., and/or make formal presentations in the form of after-action reports, accountability documents, etc.
Must possess the ability to compute, analyze and interpret numerical data for reporting purposes.
Essential Physical Functions
Must be able to see computer screens, fine print labels, and detect color coding. Member must possess hearing adequate to decipher normal conversation. Member should be able to use fingers for activities such as typing or other work without the use of the entire hand as well as be able grasp with entire hand. Member must be able to use hands, arms, and shoulders for reaching and lifting above shoulders.
Member must be able to perform repetitive motions with wrist, hands and fingers such as typing for sustained periods. Must be able to sit or stand for sustained periods of approximately 4 hours.
Must be able to maintain body equilibrium (balance while standing, kneeling, bending or crouching) while navigating the work environment.
Must be able to ascend or descend stairs and be able to perform moderate carrying of items weighing from 15 to 44 pounds. Member must possess the ability to move around enough to support transit.
Hyperion is an equal opportunity employer and does not discriminate in hiring or employment on the basis of race, color, religion, sex, national origin, age, disability, or any other basis prohibited by federal, state, or local law. You may self-identify on a voluntary basis.
No question on this application is intended to secure information to be used for such discrimination. The company is required by federal regulations to report information as requested on the form. Your contribution of this information is completely voluntary and in no way affects the decision regarding your employment opportunity. The information you provide is strictly confidential.