Clinical Regulatory and Operations Specialist

This position is located in the U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Operations (OCRPRO). If selected for the position, you will perform the following duties: Serve as the NIAID in-country/on-the-ground lead and authority in managing, overseeing, and coordinating clinical research operations during public health emergencies caused by emerging and re-emerging infectious diseases, with an emphasis on international clinical research. Conduct frequent site visits to ensure continuity of operations and confirm sites are operating under all applicable regulations, guidelines, policies, and standards. Develop and assemble Investigational New Drug (IND) submissions in close coordination with various research offices and committees of the DCR, contractors and pharmaceutical companies responsible for pre-clinical screening, and administrative collaboration with principal investigators responsible for clinical trial protocols. Represent NIAID at meetings, conferences, and symposia and participate as an authority on matters relating Investigational New Drug (IND) and Investigational Device Exemption (IDE) development, oversight and evaluation, and FDA regulations. Develop and maintain DCR policies related to the Independent Safety Monitor (ISM), Safety Monitoring Committee (SMC), and DSMB. To qualify for the Clinical Regulatory and Operations Specialist GS-601, you must meet the following qualification requirements: Education Requirement: You must possess a Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. AND Additional Qualifications: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: coordinating clinical research operations in response to emerging and re-emerging infectious diseases; supporting the development, technical management, and evaluation of clinical research programs; providing guidance on matters relating to Investigational New Drug (IND) and Investigational Device Exemption (IDE) development, oversight and evaluations; overseeing clinical studies to ensure procedures and policies are within safety protocols. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/13049100 This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.