This position is located in the Operations and Strategic Management Section (OSMS), Collaborative Clinical Research Branch (CCRB), Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS). DCR's vision is to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious diseases.

Duties

If selected for the position, you will perform the following duties: Serve as NIAID's authority in a designated national or international location. Provide biomedical, technical, scientific, and managerial leadership and support for NIAID in response to high consequence emerging infectious disease threats within the designated location. Collaborate with physicians and research staff in the development, review, management, and evaluation of research protocols. 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 activities often conducted in resource poor developing countries (RPDC). Coordinate a complex rapid research response to high consequence emerging disease threats in RPDC; represent NIAID and NIH interests and speaks on behalf of leadership when meeting with the highest levels of US and foreign governments to make urgent time-sensitive decisions and authorize the allocation and utilization of resources. Direct start-up activities including initial oversight of study/site budgets and contracts, global geographic deployment, and country/site protocol approvals. Provide organizational leadership and clinical research expertise in establishing program objectives, goals, and timelines for strategic and operational plans; identifies risk and mitigation strategies to achieve scientific outcomes and accommodate resource requirements; and, continually refines processes to optimize the execution of clinical research priorities and initiatives. Conduct frequent site visits to ensure continuity of operations and confirms sites are operating under all applicable regulations, guidelines, policies, and standards.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• Position requires Education (You are strongly encouraged to submit a copy of your transcripts).

Qualifications

To qualify for the Clinical Research Specialist GS-601-14, you must meet the following qualification requirements: Education Qualification: You must possess a Bachelor's degree, or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this 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: In addition, you must have at least one year of qualifying specialized 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: providing operational expertise in the oversight of clinical research, safety oversight issues, and day-to-day research management issues; collaborating with physicians and research staff in the development, review, management, and evaluation of research protocols; directing, overseeing, and evaluating clinical research studies; and establishing procedures to safeguard the quality and integrity of data at clinical sites. 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. 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. 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/12549443

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: Teresa Collins
• Phone: 301-761-5348
• Email: [email protected]