Duties

Summary

The ideal candidate will have a clinical background and experience managing or coordinating multiple initiatives pertaining to the development and operation of clinical research studies and practices.
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Responsibilities

• Collaborates with multiple disciplines in the implementation of clinical studies.
• Recommends and oversees appropriate methods to collect, enter, and analyze data generated from clinical studies.
• Serves as a liaison to groups outside the NIH to promote patient referrals for clinical studies.
• Develops and participates in quality assurance activities to assure a high level of patient safety, protocol compliance, and data integrity within research studies managed by the OCD.
• Provides education regarding changes in regulatory requirements and oversight of clinical research.
• Develops annual budget for the OCD that ensures adequate provision of services.
• Assists in research protocol design.

Travel Required

Not required

Supervisory status
Yes

Promotion Potential
14

Requirements

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 has an education requirement- please provide transcripts.
• 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.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.

Qualifications

You qualify at the GS-14 level, if you meet the following qualification requirements:

A. You must demonstrate in your resume at least one (1) year of qualifying 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: coordinating clinical trial activities for an organization; serving as a subject matter expert regarding the regulatory requirements involved in executing clinical trials; managing multiple initiatives pertaining to the development of clinical trials services for an organization; and providing input regarding administrative support as relates to clinical trials services;

AND

B. Possess a Bachelor's degree, or graduate/higher level degree with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this 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).

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.

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/10516359

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

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 "nonemergency/ teleworker" employee. In the event of a closure, you must be available to telework or request leave.
• A one-year supervisory probationary period may be required upon selection/placement.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• 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 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).
• 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.

How You Will Be Evaluated

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

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 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

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Credentialing , Suitability/Fitness

Required Documents

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 need to 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 Cente r, and the USAJOBS Resume Writing Video Tutorial.

ASSESSMENT QUESTIONNAIRE:

You must submit a completed assessment questionnaire.

All of the above information is necessary to determine your qualifications for the position. Please help us make an informed decision regarding your eligibility by providing complete and thorough information on your experience and qualifications. Not providing all of 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, or Schedule A 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.

Required Documentation for Schedule A Eligibility (Applicants with Disabilities)

Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify your eligibility. Such documentation 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.

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.

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.

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.