This position is located in the Malaria Infection Biology and Immunity Unit (MIBIU), Laboratory of Immunogenetics (LIG), Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS).

Duties

If you are selected for this position, you will perform the following duties: Process and guide multiple and varied research protocols under NIAID IRB auspices through the review cycle of submission, initial review, continuing review, amendments, and reporting. Read, review, and become familiar with content of the individual protocols, consents, and actions under IRB review. Recommend changes to improve subject safety and to enhance regulatory compliance. Serve as a primary contact point for the laboratory in regard to protocol procedures, regulations and requirements. Provide guidelines and advice concerning regulatory compliance and quality assurance issues pertaining to clinical trials. Serve as the liaison between various individuals and offices involved in the oversight of human subjects research at NIH including, but not limited to the NIAID IRB, the NIAID Clinical Director, the Office of Human Subjects Research, the Clinical Center Office of Protocol Services, Deputy Ethics Coordinators, Technology Transfer offices, and investigations. Work to maintain NIAID IRB protocol and office files, databases, and records. Develop guidance materials, manuals, and other written and electronic resources on IRB processes and functions. If you are selected at the GS-12 level, you will essentially perform the same duties as those at the full performance level described, however, duties are less complex and will be performed under closer supervision with more detailed guidance.

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.

Qualifications

Education Requirement You must have 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 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 In order to qualify for the GS-12 level: You must at least one year of qualifying experience specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: reviewing clinical research protocol submissions to ensure accuracy; providing technical guidance on clinical research protocol procedures, regulations, and requirements; coordinating with other staff and organizations on clinical protocol reviews; and maintaining documentation and records of clinical protocols and associated procedures and processes. In order to qualify for the GS-13 level: You must have at least one year of qualifying experience specialized experience equivalent to at lease the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: managing clinical research protocol review processes; providing guidance on the regulations, policies, procedures, and requirements for clinical research protocols and clinical trails; coordinating with other staff and organizations on clinical protocol reviews; recommending safety changes to enhance regulatory compliance; and developing guidance and material to educate staff on regulatory compliance and quality assurance of clinical trails. 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/12033015

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 Dr Bethesda, MD 20892 US
• Name: Richard Woods
• Phone: 240-669-2824
• Email: [email protected]