A Program Specialist (Protocols) works to develop and implement comprehensive plans and strategies for the internal and external integration of day-to-day and long-range projects, actions and activities for the assigned organization. Such projects and programs may be in support of administrative functions or scientific research activities.

Duties

As a Program Specialist (Protocols) within the Protocol Services Section (PSS) of the Office of Research Support and Compliance, your duties will include, but are not limited to the following: In coordination with the Supervisor, administering projects to improve or extend protocol approval processing, information storage and access. Planning, scheduling, and carrying out professional and administrative work assigned. Performing processes and conducting analysis related to completing, quality review, distributing, tracking and storing of intramural protocols. Defining problems with processes, recommending alternatives for solution. Maintaining appropriate and timely written and verbal communication with supervisory regarding work flow, problem identification, and opportunities for improvement. Providing sound advice to areas and individuals within and outside the PSS, based on established NIH Policy, Food and Drug Administration (FDA), OHSRP SOPs, and CC procedures and regulations. Actively maintaining information within the intramural research database PROTRAK, and data transmitted to multiple websites by analyzing and interpreting data points for quality and accuracy. Providing guidance concerning regulatory compliance and quality assurance issues pertaining to protocols on ClinicalTrials.gov. Staying current with regulations and policies related to the protection of human subjects research, to provide assistance.

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.
• A one-year probationary period may be required upon selection/placement.
• If selected, you must pass a pre-employment medical examination.
• The work is primarily sedentary. Flexible, irregular and/or prolonged work schedules may be required for purposes of advising during crises and problem solving,
• The work environment involves everyday risks or discomforts which require normal safety precautions typical of such places as office in a medical facility. There is adequate light, heat, and ventilation in the work area.
• On occasion, the incumbent may be required to make site visits and attend local out-of-state classes, meetings, and conferences.
• At the supervisor's discretion, this position may offer work schedule flexibilities: telework, flexible schedules.

Qualifications

In order to qualify for a Program Specialist (Protocols), GS-0301 position at the GS-09 level, you must have: A. Completed a master's or equivalent graduate degree, or 2 full years of progressively higher level graduate education leading to such a degree or an LL.B. or J.D., if related; OR B. 1 year of specialized experience equivalent to at least the GS-07 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: Providing general guidance on clinical protocols; assisting in gathering and organizing information on clinical research or procedures; assisting in reviewing submitted protocols for conformance to regulations and policy; gathering information to use in responding to inquiries concerning clinical protocols and activities.; OR C. A combination of post baccalaureate education related to the position and experience that meets 100% of the qualification requirements for this position. In order to qualify for a Program Specialist (Protocols), GS-0301 position at the GS-11 level, you must have: A. Completed a Ph.D. or equivalent doctoral degree, or 3 full years of progressively higher level graduate education leading to such a degree or an LL.M., if related; OR B. 1 year of specialized experience equivalent to at least the GS-09 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: Providing administrative and technical guidance on clinical protocols; gathering and organizing information on clinical research or procedures; maintaining a protocol tracking system; reviewing submitted protocols for conformance to regulations and policy; responding to inquiries concerning clinical protocols and activities.; OR C. A combination of post baccalaureate education related to the position and experience that meets 100% of the qualification requirements for this position. A combination of education and specialized experience that meets the qualification requirements for this position. 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/12262419

Education

If you qualify based on education in lieu of specialized experience, 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 packages. 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: NIH HR Service Desk Branch E
• Email: [email protected]