This position is located in the Office for Policy in Clinical Research Operations (OPCRO), Division of AIDS (DAIDS), 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: As a senior TMF Expert/Consultant within the OPCRO Front Office with primary responsibility for providing consulting services to develop comprehensive strategies and processes to assist in the development, implementation, and maintenance of DAIDS electronic Trial Master Files (eTMFs) to meet regulatory requirements. Ensures compliance with the requirements of U.S. Federal regulations, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) , and DAIDS policies and procedures. Develop, modify, and maintain SOPs as required and advises DAIDS scientific programs and research teams regarding DAIDS TMF activities and requirements. Evaluates the effectiveness of, and compliance with, relevant regulations and procedures, and initiates policy and procedural changes to improve the operation and management of DAIDS TMFs. Collaborate and communicate with a large stakeholder base to accomplish complex TMF work activities to support DAIDS scientific portfolio. Coordinate and communicate with other DAIDS, NIAID, and NIH components to ensure consistency and harmonization of TMF procedures, strategies, and best practices as required to support DAIDS scientific portfolio. Provide guidance and training on TMF regulations and procedures to DAIDS researchers and to domestic and international research organizations involved in DAIDS-sponsored clinical trials.

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 Health Scientist GS-601-13 position you much have: Education Requirement: 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). Specialized Experience: I have at least one (1) full year of qualifying specialized experience equivalent to at least the GS-12 level in the Federal Service obtained in either the private or public sector that equips me with the knowledge, skills and abilities required to successfully perform the duties of this position, such as the following: evaluating a Trial Master Files (TMFs) landscape to prepare for future systemic needs for clinical research programs; providing guidance and consultation to management officials and scientific staff on TMF strategies, procedures, and requirements; assessing compliance of TMFs with applicable laws, regulations, policies, and procedures; coordinating and collaborating with other staff and organizations on TMF activities and requirements; and providing guidance and training on TMF activities to scientific staff and other research organizations. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12247757

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: Susie Yi-Miller
• Phone: 301-761-7051
• Email: [email protected]