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The NIH Clinical Center is seeking a Protocol Monitoring Specialist to serve as an expert in providing research quality assurance and compliance oversight to investigators and teams within the Intramural Research Program (IRP). The ideal candidates will have experience as relates 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).

Learn more about this agency

Help

Accepting applications

Open & closing dates

11/21/2024 to 11/25/2024
Salary

$99,200 - $153,354 per year
Pay scale & grade

GS 12 - 13
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Location

1 vacancy in the following location:
- Montgomery County, MD
Remote job

No
Telework eligible

Yes—as determined by the agency policy.
Travel Required

Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed

No
Appointment type

Permanent
Work schedule

Full-time
Service

Competitive
Promotion potential

13
Job family (Series)
- 0601 General Health Science
Supervisory status

No
Security clearance

Other
Drug test

No
Position sensitivity and risk

Non-sensitive (NS)/Low Risk
Trust determination process
- Credentialing
- Suitability/Fitness
Financial disclosure

No
Bargaining unit status

No
Announcement number

NIH-CC-DE-25-12591236
Control number

818554000

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Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This job is also open to USPHS Commissioned Corps Officers and Call-To-Active Duty (CAD) Candidates.

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Reviewing human subject research protocols and evaluates them to identify issues that must be monitored to ensure regulatory compliance with process and documentation requirements and with pertinent laws and regulations.
Conducting risk assessments of various research protocols in the IRP.
Creating a monitoring and auditing process to address areas identified by the risk assessments related to research compliance areas for the organization.
Developing and implements systems for tracking and trending clinical research quality assurance findings.
Developing and conducting focused education and training based on findings from risk assessments and audits, enforcement activities, and new policies and regulations.
Assisting with the development of standard operating procedures (SOP)'s for monitoring and evaluating regulatory compliance for clinical research and quality assurance activities.
Identifying the need for and designs customized audit and evaluation surveys to ensure that protocols meet regulatory requirements, policies and standards and that research funds are being used as identified in the protocol.

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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 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: Alternative work schedule and Telework.
This position is designated as an "non-emergency/teleworker" position. See definition of this designation in the Additional Information Section of this announcement.
If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.

Qualifications

Education Qualification Requirement for GS-12 and GS-13:

In order to qualify for a Protocol Monitoring Specialist-GS-601, position you must have successfully completed 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-12:

In addition, in order to qualify for an Protocol Monitoring Specialist-GS-601, at the GS-12 level, you must have at least one year of qualifying specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks:interpreting and applying knowledge of various regulations, policies and procedures governing human subject research and investigational drug and devices research; applying a wide range of qualitative and/or quantitative methods for the assessment and compliance of human subject protocols and the improvement of complex management and medical processes and systems; developing and implementing systems for tracking and trending clinical research quality assurance findings; preparing a variety of materials including briefings, project papers, correspondence and presentations; and preparing reports of monitoring and/or audit findings and recommendations.

Additional Qualification Requirement for GS-13:

In addition, in order to qualify for an Protocol Monitoring Specialist-GS-601, at the GS-13 level, you must have at least one year of qualifying specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: conducting research quality assurance review of 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 monitoring plans and/or audits of protocols meet regulatory requirements and policies and standards; developing and conducting education and training based on findings from audits and new policies and regulations; and developing SOPs for monitoring and evaluating regulatory compliance for clinical research and quality assurance activities.

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/12591236

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.

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.
A one-year probationary period may be required upon selection/placement.
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 within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
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 our Applicant FAQs page for helpful information on the application process.
Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.
If selected, you may be eligible to receive a salary above the minimum based on superior qualifications and/or a special need of the Government for your services. This applies to employees paid under the General Schedule (GS) and Federal Wage System (FWS) pay systems and is at the discretion of the hiring manager. A salary above the minimum must be approved before the appointment.

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Review our benefits

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

1. Knowledge of medical research.
2. Ability to conduct evaluations and studies of research protocols.
3. Ability to communicate technical information to a variety of professional staff.
4. Ability to prepare a variety of written technical materials.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

Best Qualified - for those who are superior in the evaluation criteria
Well Qualified - for those who excel in the evaluation criteria
Qualified - for those who only meet the minimum qualification requirements

The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

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Review our benefits
As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:
1. Job title
2. Name of employer
3. Beginning and ending dates of employment (month/day/year format)
4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
6. Series and grade or equivalent (if a federal position)
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 Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.

ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
- Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
- Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
- Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
- Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.
The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

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.

Do not submit 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.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 11/25/2024 to receive consideration.
1. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
2. 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.
3. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, 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.
4. Complete the assessment 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 assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12591236
5. Verify all required documentation is included in your application package, review your responses to the assessment 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.

NIH's EEO and Diversity and Inclusion Policy Statement

Visit the NIH's Office of Equity, Diversity, and Inclusion site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.
Agency contact information

NIH HR Service Desk Branch E

Email

ohrcsdbranchesrvdsk@od.nih.gov

Address

National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US

Learn more about this agency

Next steps

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

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.

Help

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

Job title
Name of employer
Beginning and ending dates of employment (month/day/year format)
Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
Series and grade or equivalent (if a federal position)

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 Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.

ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

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.

Do not submit 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.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

Help

To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 11/25/2024 to receive consideration.

To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
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 (Status Applicant, Reinstatement, 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 assessment 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 assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12591236
Verify all required documentation is included in your application package, review your responses to the assessment 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.

NIH's EEO and Diversity and Inclusion Policy Statement

Visit the NIH's Office of Equity, Diversity, and Inclusion site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.

Agency contact information

NIH HR Service Desk Branch E

Email: ohrcsdbranchesrvdsk@od.nih.gov
Address: National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US

Learn more about this agency

Next steps

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

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.

Help

Accepting applications

Open & closing dates

11/21/2024 to 11/25/2024
Salary

$99,200 - $153,354 per year
Pay scale & grade

GS 12 - 13
Location

1 vacancy in the following location:
- Montgomery County, MD
Remote job

No
Telework eligible

Yes—as determined by the agency policy.
Travel Required

Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed

No
Appointment type

Permanent
Work schedule

Full-time
Service

Competitive
Promotion potential

13
Job family (Series)
- 0601 General Health Science
Supervisory status

No
Security clearance

Other
Drug test

No
Position sensitivity and risk

Non-sensitive (NS)/Low Risk
Trust determination process
- Credentialing
- Suitability/Fitness
Financial disclosure

No
Bargaining unit status

No
Announcement number

NIH-CC-DE-25-12591236
Control number

818554000

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/818554000. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

Protocol Monitoring Specialist

Summary

Overview

Open & closing dates

Salary

Pay scale & grade

Location

Remote job

Telework eligible

Travel Required

Relocation expenses reimbursed

Appointment type

Work schedule

Service

Promotion potential

Job family (Series)

Supervisory status

Security clearance

Drug test

Position sensitivity and risk

Trust determination process

Financial disclosure

Bargaining unit status

Announcement number

Control number

This job is open to

Clarification from the agency

Duties

Requirements

Conditions of Employment

Qualifications

Education

Additional information

How You Will Be Evaluated

Required Documents

If you are relying on your education to meet qualification requirements:

How to Apply

Agency contact information

Next steps

Fair & Transparent