This is an exciting opportunity in the NIDDK clinical studies and central repository programs, to work with extramural Program staff and NIDDK-funded study groups to harmonize clinical research practices and participate in NIDDK Central Repository operations.Learn more about this agency
While at least a 4-year degree related to the medical field, health sciences or allied sciences is required, a post-baccalaureate degree or advanced training in an academic field related to public health or epidemiology is preferred.
As a Clinical and Repository Program Specialist, your typical work assignments may include:
- Coordinating Repository interactions with NIDDK-funded study groups, ensuring timely transfer of data and samples to the Repository, reviewing and approving external requests for access to Repository materials, developing and monitoring policies and guidance to adhere to NIDDK/NIH policies, and managing data and biospecimens for statistical analyses and scientific review.
- Providing assistance, technical direction, and oversight of the performance of the NIDDK Central Repository contractors.
- Collaborating with several leadership teams to develop and implement policies, procedures, and oversight tools to guide extramural NIDDK-funded clinical studies, enhance the effectiveness of clinical research activities, and achieve consistent, effective, and efficient clinical research practices across all NIDDK divisions.
- Independently analyzing and interpreting Federal research regulations and NIH policies for grants, cooperative agreements, and contracts. Developing and implementing best practices to ensure that all clinical studies are compliant with NIH, NIDDK, and HHS regulations and policies, and providing advice and guidance to Program Directors to ensure they are applied consistently and correctly across all studies.
- Developing cost principles for clinical study budgets and assisting individual Program Directors in developing budget projections for specific studies.
Occasional travel - You may be expected to travel for this position.
Job family (Series)
Conditions of Employment
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- Position is subject to a background investigation.
- This position requires financial disclosure.
- 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.
- The position has a positive education requirement.
QualificationsYou qualify at the GS-14 level, if you meet the following qualification requirements:
Basic Education Requirements:
Bachelor's or graduate/higher level degree: 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.
Minimum Qualification Requirements for GS-14 Level:
I qualify for this position at the GS-14 level because I have 1 year of specialized experience equivalent to at least the GS-13 level in the federal service obtained in either the private or public sector, performing the following types of tasks: providing advice and guidance to stakeholders on the policies, practices and procedures relevant to a central repository program (bio-sample, genetic, and data) in support of clinical studies; managing repository program data and bio-specimens for statistical analyses and scientific review; implementing new initiatives to promote utilization of repository data and samples and refining sample culling practices; developing policies and procedures to guide clinical studies or depository program use; developing cost estimates for clinical study budgets; and establishing and managing tracking databases of clinical studies funded by an organization.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10445552
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.
If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
- 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 also apply online to this announcement in order to receive consideration.
- We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) 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 HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
- 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.
- At the supervisor's discretion, this position may offer work schedule flexibilities: [telework].
- If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/topics/fd.htm.
- A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
To determine your qualifications and referral status, a review of your resume and supporting documentation may be made and compared against your responses to the vacancy questionnaire. Because your rating is based on both your responses to the questionnaire and documentation you submit, please make sure that your self-ratings are supported by the information you provide in your application. Your qualifications and self-ratings may be verified at any time during the application and selection process through quality review, interview questions, work samples, demonstrations, reference checks, and any other means. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts on the assessment questionnaire or in any other materials you submit in support of your candidacy (including but not limited to the application), or in any oral statements you may make during the selection process shall be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.
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 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.
Background checks and security clearance
Drug test required
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 theUSAJOBS 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)
For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.
You must submit a completed assessment questionnaire.
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 human resources office or, if you are an HHS employee, from your eOPF. If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration.
- - Veteran Documentation for eligibility purposes only: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have 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 preference eligibles, 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.
- - Schedule A (Disability Appointment): Documentation of eligibility for employment under Schedule A can 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. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
- - Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for requirement documents and information.
- - Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP)for more information and required documentation.
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.
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. Learn 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 to Apply
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 04/26/2019 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). You will have the opportunity to upload additional documents to include in your application before it is submitted. You must submit your documents through the online application. Unfortunately, we cannot accept emailed or mailed documents. NOTE: that your uploaded documents may take several hours to clear the virus scan process.
3. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. NOTE: You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, including veterans' preference, regardless of what documentation you submit. We use these questions to assist in determining your eligibility for appointment, preference, and consideration. We cannot assume you intended to respond differently to a question based on other information in your application package. We cannot accept responsibility for granting you eligibility for something you did not claim other than what you provided us in the questionnaire.
4. Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. NOTE: We will only consider you for the grades, series, and specialties that you self-identify as being qualified for. We cannot assume you intended to respond differently to a qualification question based on other information in your application package. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10445552
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 the following although they are not required at the time of application (these documents may be requested later in the process).
- - Cover letter
- - Copy of transcripts (if applicable). Official transcripts will be required if selected.
- - Copy of current, valid, unrestricted professional license/registration (if applicable).
We cannot assume responsibility or grant extensions for personal issues (e.g., power outage, 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 firstname.lastname@example.org.
If you need any other accommodation or assistance with applying please contact Monet Furr at email@example.com. 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
AddressNational Institutes of Health
2115 East Jefferson Street
Rockville, MD 20851
Once you submit your application package, you will receive an acknowledgement email. Your application will be assessed to determine your qualifications and eligibility for the position. After the assessment is complete, you will be notified of the status via email. In addition, you can track the progress of your application package through your USAJOBS account.
The selecting official, hiring manager, or someone acting on their behalf will review the applications of the referred candidates and determine who to interview. We may contact you for an interview or to provide additional information after a few days or up to several months from the closing date of the announcement. We may contact you through email or phone so please ensure you have provided us with your accurate and current contact information. To remain in consideration for this vacancy announcement, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the selection and hiring process.
Fair & Transparent
The Federal hiring process is setup to be fair and transparent. Please read the following guidance.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
- An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
- An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
- An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Legal and regulatory guidance
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/530304400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.