Clinical Regulatory and Operations Specialist

Summary

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).

Duties

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. Qualifications

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

Education

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. How You Will Be Evaluated

You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed on the following competencies: Attention to Detail Customer Service Decision Making Flexibility Influencing/Negotiating Integrity/Honesty Interpersonal Skills Learning Reasoning Self-Management Stress Tolerance Teamwork Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on an assessment may also result in your removal from consideration. To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least 80 points on the assessment(s) and meet all eligibility, physical, medical, suitability, and all other requirements. Other Information

This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave. At the supervisor's discretion, this position may offer work schedule flexibilities: telework compressed schedules, flexible schedule Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration. If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/fd. We may make additional selections for similar positions across the National Institutes of Health within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at NIH. Clearance of CTAP will be applied for similar positions across NIH. The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers. The NIH maintains a tobacco free work environment and campus. Must be able to perform the essential duties of the position, with or without reasonable accommodation. Visit Help Applying for helpful information on the application process. If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation Information Veterans' Preference only applies to Schedule A (disability appointment), HHS Reemployment Priority List (RPL) Eligibles, HHS Priority Reemployment List (PRL) Eligibles, and Veterans Recruitment Appointments (if applicable).