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.
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.
You must be currently employed by the National Institutes of Health, serving on a permanent appointment in the competitive service. This job is also open to USPHS Commissioned Corps Officers and Call-To-Active Duty (CAD) Candidates.
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.
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.
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 National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
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).
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.
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.
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.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed on the following competencies:
Attention to Detail
Decision Making
Flexibility
Integrity/Honesty
Interpersonal Skills
Reading Comprehension
Reasoning
Self-Management
Teamwork
Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on an assessment may also result in your removal from consideration.
To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least 80 points on the assessment(s) and meet all eligibility, physical, medical, suitability, and all other requirements.
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.
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.
RESUME: Your resume must clearly demonstrate, in two pages or less, how your skills and experiences align with the "Qualifications" section and support your questionnaire responses. While cover letters provided with your application will be shared with hiring officials, they will not be used for initial qualification determinations. We cannot assume required experience based on your work or academic history. If your resume exceeds two pages, only the first two will be reviewed. Use a legible font such as Lato, Calibri, Helvetica, or Arial, with 0.5-inch margins. Suggested formatting: 14-point for titles and 10-point for body text. You may use the USAJOBS Resume Builder or upload your own resume. If uploading, ensure it includes all required information and is organized so we can match the following to each position:
Job title
Employer name
Employment dates (MM/DD/YYYY)
Hours worked per week (full-time assumed; part-time prorated)
Detailed duties, accomplishments, skills, responsibilities, and supervisory details (if applicable)
Series and grade or equivalent (for federal positions)
If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
For resume writing guidance, please visit the following resources: NIH Help Applying, USAJOBS Resource Center, and the USAJOBS Resume Guidance If the position has an education requirement or you are qualifying on the basis of education, you need to list your education history including the type of degree and your major of study.
APPLICATION QUESTIONNAIRE:
You must submit a completed application questionnaire.
ELIGIBILITY DOCUMENTATION:
To be considered eligible, you must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.
SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your eOPF.
Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.
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.
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 hrss@nih.gov.
If you need any other accommodation or assistance with applying please contact NIH HR Service Desk Branch E at ohrcsdbranchesrvdsk@od.nih.gov. 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.
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US
Next steps
Based on your application and your responses to the application questionnaire, you may be presented with instructions on how to access the USA Hire system to complete the online assessments. The online assessments must be completed within 48 hours following the close of this announcement. You will have the opportunity to request a testing accommodation for the assessment should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
RESUME: Your resume must clearly demonstrate, in two pages or less, how your skills and experiences align with the "Qualifications" section and support your questionnaire responses. While cover letters provided with your application will be shared with hiring officials, they will not be used for initial qualification determinations. We cannot assume required experience based on your work or academic history. If your resume exceeds two pages, only the first two will be reviewed. Use a legible font such as Lato, Calibri, Helvetica, or Arial, with 0.5-inch margins. Suggested formatting: 14-point for titles and 10-point for body text. You may use the USAJOBS Resume Builder or upload your own resume. If uploading, ensure it includes all required information and is organized so we can match the following to each position:
Job title
Employer name
Employment dates (MM/DD/YYYY)
Hours worked per week (full-time assumed; part-time prorated)
Detailed duties, accomplishments, skills, responsibilities, and supervisory details (if applicable)
Series and grade or equivalent (for federal positions)
If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
For resume writing guidance, please visit the following resources: NIH Help Applying, USAJOBS Resource Center, and the USAJOBS Resume Guidance If the position has an education requirement or you are qualifying on the basis of education, you need to list your education history including the type of degree and your major of study.
APPLICATION QUESTIONNAIRE:
You must submit a completed application questionnaire.
ELIGIBILITY DOCUMENTATION:
To be considered eligible, you must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.
SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your eOPF.
Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.
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.
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 hrss@nih.gov.
If you need any other accommodation or assistance with applying please contact NIH HR Service Desk Branch E at ohrcsdbranchesrvdsk@od.nih.gov. 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.
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US
Next steps
Based on your application and your responses to the application questionnaire, you may be presented with instructions on how to access the USA Hire system to complete the online assessments. The online assessments must be completed within 48 hours following the close of this announcement. You will have the opportunity to request a testing accommodation for the assessment should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
