This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Health (Clinical Studies) Specialist-NCCAM-DE

Department:Department Of Health And Human Services

Agency:National Institutes of Health

Job Announcement Number:NIH-NCCAM-DE-13-941833

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$89,033.00 to $115,742.00 / Per Year

OPEN PERIOD:

Monday, August 12, 2013 to Tuesday, August 20, 2013

SERIES & GRADE:

GS-0601-13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location:
Montgomery County, MD United StatesView Map

WHO MAY APPLY:

United States Citizens

JOB SUMMARY:

The NIH is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visit NIH Overview

The National Center for Complementary and Alternative Medicine (NCCAM) focuses on scientific research on complementary and alternative medicine (CAM).  The mission of NCCAM is to define, through rigorous scientific investigation, the usefulness and safety of the complementary and alternative medicine interventions and their roles in improving health and health care.  The Office of Clinical and Regulatory Affairs (OCRA) within NCCAM oversees clinical research supported by NCCAM, which is conducted by investigators supported by grants, cooperative agreement or contract mechanisms.  OCRA provides the Center with expertise in support and oversight of biostatistics, epidemiology, clinical studies, and federal regulatory requirements for the conduct of clinical research.   

 

If you are an exceptionally talented, knowledgeable, and motivated individual interested in joining a dynamic team of professionals overseeing clinical research, you should consider a Health (Clinical Studies) Specialist position with the National Center for Complementary and Alternative Medicine (NCCAM), Office Clinical and Regulatory Affairs (OCRA).

KEY REQUIREMENTS

  • U.S. Citizenship requirement met by closing date.
  • Position is subject to a background investigation.
  • Educational Requirement.
  • Confidential Financial Disclosure Form OGE 450 required.
  • Overnight travel 1-3 nights per month required.

DUTIES:

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  • Reviews and tracks data collected on the NCCAM clinical research portfolio.
  • Plans, develops, and implements oversight of targeted research programs.
  • Reviews and manages patient safety data, implementing necessary changes in study conduct based on safety data.
  • Directs development and maintenance of standard operating procedures for adverse event data collection, processing and reporting systems.
  • Performs oversight/management pertaining to the regulatory and procedural aspects of clinical site monitoring and performance evaluation.
  • Oversees tracking of Investigational New Drug (IND), Investigational Device Exemption (IDE) and Pre-Marketing Applications (PMA), progress reports, and other related paperwork.

 


QUALIFICATIONS REQUIRED:

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In order to meet the minimum qualification requirements for this position, you must possess the following Basic Requirements and specialized experience:    

 

Basic Requirement:  To be minimally qualified, applicants must meet the Basic Education Requirement:  Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree that included major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position. 

 

To Qualify at the GS-13 level:  In addition to meeting the basic requirements, you have to have at least one year of qualifying 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:  planning, developing and implementing targeted research programs; managing protocol development for clinical studies and ensuring protocol compliance within appropriate guidelines; reviewing adverse events; filing, reporting, and conducting analyses in accordance with policy; performing oversight management of regulatory and procedural aspects of clinical site monitoring; managing activities related to the operational protocol review committees and data and safety monitoring boards; and serving as a resource with respect to protocol development, implementation, clinical site monitoring and study performance evaluation.  

 

 

View Assessment Questions


This position has an education requirement. You must 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; however, official transcripts will be required prior to receiving an official offer.  Click here for information on Foreign Education .  If you are currently or were previously in this occupation series you do not need to submit transcripts. Instead, submit an SF-50 showing the appointment in this occupational series.

Males born after December 31, 1959 must be registered with Selective Service.

HOW YOU WILL BE EVALUATED:

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

Candidates determined to be Best Qualified will be referred to the hiring manager for further consideration and possible interview. 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.

If you are a veteran, CTAP or ICTAP eligible, or an individual with a disability, please refer to the following links for additional information and required documents:

All such documents MUST be received by 11:59pm ET of the closing date,  Tuesday, August 20, 2013, to be considered.


BENEFITS:

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The federal government offers a comprehensive benefits package including vacation, sick leave, holidays, life insurance, health benefits, and participation in the Federal Employees Retirement System.  For more information, check out New Employee Benefits at NIH and OPM's Employee Benefits Information.

OTHER INFORMATION:

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 are unable to pay relocation expenses.

 

A one-year probationary period may be required upon selection/ placement.

 

NIH may repay certain outstanding Federally-insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.

 

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. The use of this service credit incentive is at the discretion of the selecting official and service credit is granted only for a position deemed hard-to-fill.

 

If selected, you will be required to complete 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.

 

Additional selections may be made through this vacancy announcement. 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 TO APPLY:

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Submission of a resume alone IS NOT a complete application. You must provide a complete online Application Package which includes:

 

  • Your Resume (Please provide sufficient details in your resume to enable us to determine if you meet the requirement for qualifying experience (as stated in the Qualifications section) and to support your answers to the online questionnaire. Providing insufficient details in your resume may result in a lower or ineligible rating.)
  • A complete Assessment Questionnaire, View Assessment Questions.
  • Other required supporting documents (See the Required Documents section for any additional forms and/or supplemental materials required.)
  • If you would prefer to submit a Curriculum Vitae (CV) for consideration, you may submit a skeletal online resume and Fax your CV. Submission of a resume/CV alone IS NOT a complete application. You must complete the online questionnaire that will appear when you begin your application on USAJOBS. (See the Required Documents section for any additional forms and/or supplemental materials required.)

 

To begin the online application process, click the "Apply Online" button at the bottom of this screen to log in to your existing USAJOBS account or to create an account if you do not already have one.

 

  • Follow the prompts to complete the Assessment Questionnaire. Please ensure you click the "Submit My Answers" button at the end of the process.
  • To fax supporting documents you are unable to upload, you must use the fax coversheet found at http://staffing.opm.gov/pdf/usascover.pdf . Include the vacancy announcement number for the job to which you are applying, 941833. Fax your documents to 1-478-757-3144.

 

If you have questions or require reasonable accommodation during the application process, please contact the HR staff member listed below. If you cannot apply online, these are the steps to follow:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, View Occupational Questionnaire.
  2. Print this 1203-FX form to provide your response to the occupational questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf.
  3. In Section 25 of the Occupational Questionnaire, you may notice that the numbering restarts with number one. When entering your responses on the 1203-FX form please continue to enter your responses on the next available number within this section. The numbers on the 1203-FX will not match the Occupational Questionnaire once it restarts with number one. This issue has been identified and will be resolved as soon as possible.
  4. Fax the completed 1203-FX form along with any supporting documents to 1-478-757-3144. Your 1203-FX will serve as a cover page for your fax transmission.

 

NOTE: Faxing paper applications will overwrite your prior online application responses and may result in you being found ineligible.

 

If you have difficulties with hearing and are seeking assistance, please call a relay operator at 1-800-735-2258 or visit Maryland Relay or AT&T Relay.

 

For technical difficulties, contact HR Systems Support between 8 AM and 4:30 PM ET Monday through Friday at 301-451-1436 or hrsystemssupport@mail.nih.gov.

 

Additional Information on How to Apply

Information on Reasonable Accommodation

 

We encourage you to verify that your application is complete. Log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.



REQUIRED DOCUMENTS:

The following information must be received by 11:59pm ET on the closing date of the announcement, Tuesday, August 20, 2013.  

  1. Resume via USAJOBS.
  2. Responses to online questionnaire.
  3. If applicable, supporting documentation (including DD214 to support Veterans' Employment, CTAP/ICTAP, Schedule A, or other information requested in the announcement such as transcripts). To ensure your information is secure, please block out any Social Security numbers (SSNs). Clean copies may be requested if you are hired.

AGENCY CONTACT INFO:

Christine Centeno
Phone: (301)435-3415
Email: CENTENOC@MAIL.NIH.GOV
Agency Information:
National Institutes of Health
2115 E Jefferson St
Bethesda, MD
20892

WHAT TO EXPECT NEXT:

Within 15 business days of the closing date, Tuesday, August 20, 2013, you may check your status online at USAJOBS.  We will update your status after each key stage in the application process has been completed.

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Job Announcement Number:

NIH-NCCAM-DE-13-941833

Control Number:

349405300