The ideal candidates will possess a bachelors degree in the health sciences or allied scientific field and have experience supervising Protocol Monitoring Specialists perform duties that relate to research quality assurance, clinical research, and federal regulations that govern human subjects and investigational drug and devices research (45 CFR 46 and 21 CFR 312 and 21 CFR 812).

Duties

Supervising and leading a staff of Protocol Monitoring Specialists within the Protocol Monitoring Section to ensure compliance with regulations, guidance, NIH policy, and the protocol. Formulating and planning specialized projects to ensure quality assurance of human research protocols. Interpreting and applying the regulatory knowledge of 45 CFR 46 (Common Rule for the Protection of Human Subjects in Clinical Research), 21 CFR 312 (Investigational New Drugs), and 21 CFR 812 (Investigational Device Exemptions). Developing and conducting trainings based on findings from audits, new policies, and information from the U.S. Federal Drug Administration (FDA), accrediting organizations, and professional organizations. Designing customized audits and evaluation surveys to ensure that protocols meet regulatory requirements and policies and standards. Providing research quality assurance guidance and compliance oversight for investigators and teams within an Intramural Research Program. Developing performance standards and evaluating work performance of subordinates.

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.
• This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
• At the supervisor’s discretion, this position may offer work schedule flexibilities: telework.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450. See the "additional information" section of this announcement for details.
• Position is designated as an "non-emergency/teleworker" position. See definition of this designation in the Additional Information Section of this announcement.

Qualifications

Education Qualification Requirement for GS-14: In order to qualify for a Supervisory Protocol Monitoring Specialist-GS-601, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to 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 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). Additional Qualification Requirement for GS-14: In addition, in order to qualify for a Supervisory Protocol Monitoring Specialist-GS-601, at the GS-14 level, you must have at least one year of qualifying specialized experience equivalent to at least the GS-13 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: supervising and leading a staff that performed duties in relation to research quality assurance, clinical research, and federal regulations that govern human subjects and investigational drug and devices research (45 CFR 46 and 21 CFR 312 and 21 CFR 812); conducting quality assurance research and clinical research that govern human subjects and investigational drug and devices research; formulating, planning and executing specialized projects to ensure quality assurance of human research protocols; designing customized audit and evaluation surveys to ensure that protocols meet regulatory requirements and policies and standards; and developing and conducting education and training based on findings from audits and new policies and regulations. 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/12179551

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: NIH HR Service Desk Branch E
• Email: [email protected]