Summary

The ideal candidate has experience reviewing clinical research protocols and ClinicalTrials.gov documentation; providing guidance on regulatory and IRB requirements; monitoring compliance with submission requirements; working with investigators and research staff to resolve protocol-related issues; and mentoring and training staff on clinical research processes, regulatory requirements, and best practices.

Duties

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• Identifying, assigning, distributing and balancing workload and tasks among employees in accordance with established workflow, skill level and/or occupational specialization.
• Ensuring that each employee has an integral role in supporting protocol actions that are approved by the IRB and submitted to the PSS for final review and processing by staff.
• Developing and implementing program strategies that support protocol processing, information management, and administrative services for the NIH Intramural Research Program (IRP) to ensure effective support of clinical research activities.
• Providing oversight of protocol action processing by conducting quality assurance reviews to ensure accuracy, consistency, and compliance with established procedures.
• Serving as a principal liaison for the NIH Intramural Research Program to support implementation of and compliance with ClinicalTrials.gov registration requirements for human subjects' research protocols.
• Identifying and implementing process improvements by analyzing, streamlining, and automating administrative workflows.

Requirements

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Conditions of employment

• 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.
• At the supervisor's discretion, this position may offer work schedule flexibilities: flexible schedules.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• Position is designated as an "non-emergency/teleworker" position. See definition of this designation in the Additional Information Section of this
  announcement.

Qualifications

In order to qualify for a Lead Program Specialist (Protocol) at the GS-13 grade level, you must have1 year of specialized experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: 1.) reviewing and evaluating clinical research protocols, amendments, renewals, and related documentation to identify deficiencies and ensure compliance with applicable Federal regulations, policies, and Institutional Review Board (IRB) requirements; 2.) providing technical guidance to investigators, protocol coordinators, and research staff regarding protocol development, submission requirements, regulatory compliance, and IRB processes, including requirements established by Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and Office of Human Research Protection (OHRP); 3.) monitoring research protocol activities to identify compliance concerns, resolve procedural or documentation issues, and support continued adherence to regulatory and institutional requirements; 4.) analyzing and maintaining protocol related information to support the planning, tracking, and evaluation of research activities and associated program resources; and 5.) serving as a technical resource to investigators, protocol coordinators, and other staff by clarifying protocol requirements, addressing submission or compliance issues, and facilitating the resolution of protocol-related concerns.

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.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer.

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Education

This job does not have an education qualification requirement.

Additional information

• This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
• Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
• We may make additional selections for similar positions across the National Institutes of Health within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at NIH. Clearance of CTAP will be applied for similar positions across NIH.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• Visit Help Applying for helpful information on the application process.
• If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation Information
• Veterans' Preference only applies to Schedule A (disability appointment), HHS Reemployment Priority List (RPL) Eligibles, HHS Priority Reemployment List (PRL) Eligibles, and Veterans Recruitment Appointments (if applicable).

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

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Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.