Lead Program Specialist (Protocol)

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

• 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.

Qualifications

In order to qualify for a Lead Program Specialist (Protocol) at the GS-13 grade level, you must have 1 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/13051424

How to apply

Please read the entire announcement and all the instructions before you begin an application. To apply and be considered for this position, you must complete and submit all required questionnaires, assessments, and required documentation as specified in the How to Apply and Required Documents sections. The complete application package must be submitted by 11:59 PM (ET) on the closing date of the announcement to receive consideration. The application process is as follows: Click Apply Online button. Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Veteran, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package. Complete the application questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/13051424 After submitting an online application, you will be notified whether or not you are required to take additional online assessments through the USA Hire Competency Based Assessment system. This message will be delivered to you via email notification. The email may be routed to your "Spam" or "Junk" folder. If you are required to complete any USA Hire Assessments, you will be notified after submitting your application. The notification will be provided in your application submission screen and via email. The notification will include your unique assessment access link to the USA Hire system and the completion deadline. Additionally, in USAJOBS you can click "Track this application" to return to your assessment completion notice. Access USA Hire using your unique assessment link. Access is granted through your USAJOBS login credentials. Review all instructions prior to beginning your assessments. You will have the opportunity to request a testing accommodation before beginning the assessments should you have a disability covered under the Rehabilitation Act of 1973 as amended. Set aside about 2 hour to take the USA Hire assessments; however, most applicants complete the assessments in less time. If you need to stop the assessments and continue later, you can re-use your unique assessment link. Your responses to the USA Hire Assessments will be reused for one year (in most cases) from the date you complete an assessment. If future applications you submit require completion of the same assessments, your responses will be automatically reused. Verify all required documentation is included in your application package, review your responses to the application questionnaire for accuracy, and then submit your application. Visit the USA Hire Applicant Resource Center for practice assessments and assessment preparation resources at https://support-usahire.opm.gov/hc/en-us. In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later. We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at [email protected]. If you need any other accommodation or assistance with applying please contact NIH HR Service Desk Branch E at [email protected]. Requests for reasonable accommodations must be made before the announcement closing date. Visit our site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.