This position is located in the Office of Clinical Research Policy and Regulatory Operations (OCRPRO), 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).

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.

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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Education (You are strongly encouraged to submit a copy of your transcripts.)
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.

Qualifications

To qualify for the Clinical Regulatory and Operations Specialist GS-601-14 level, if you meet the following qualification requirements: Education Qualifications: 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). 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: 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; and 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12157967

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: Marisa Smith
• Phone: 3014964867
• Email: [email protected]