Experience:
1-3 years of experience
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Employment Type:
Part time
Posted:
7/31/2016
Job Category:
Administration
Industry:
Health Care & Medicine
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Program Assistant - Institutional Review Board Coordinator
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Job Description

This position is organizationally aligned under the Research and Development Service Line at the Jesse Brown

VA Medical Center in Chicago, IL. This position provides procedural and administrative support and management for the Institutional Review Board (IRB) which reviews all research projects involving human subjects conducted by VA personnel at any institution by non-VA personnel at the VAMC. The Program Assistant - Institutional Review Board Coordinator will review research protocol files for content and compliance prior to IRB review and also review/audit PI data and office files post approval to insure continued regulatory compliance. Major duties and responsibilities are:

  • Provides direct assistance to the Associate Chief of Staff for Research (ACOS/R);
  • Reviews IRB submissions for completeness and proper content, and communicates to investigators any deficiencies found and directs them to correct submissions;
  • Assigns primary reviewers to studies for expedited review and creates correspondence authorizing appropriate action;
  • Performs pre-committee analysis of research proposals, including identifying problems and issues in the proposal, contacting the investigator and requesting additions or corrections to the proposal;
  • Determines which protocols are eligible for expedited review and recommends them to the Program Analyst (Senior IRB Administrator);
  • Maintains up-to-date knowledge of federal regulations regarding research involving human subjects;
  • Represents the Medical Center at national meetings of PRIMER/ARENA (primary IRB organizations), OHRP, FDA, and at local area IRB coordinator meetings;
  • Resolves remaining problems and discrepancies identified by committee members and initiates resolutions with investigators and forwards the responses to the committee for approval;
  • Collaborates with the Program Analyst (Senior IRB Administrator) in the analysis of adverse event reports submitted to identify changes in the prior risk assessment made by the committee;
  • Creates the agenda and prepares all submissions for the IRB meetings;
  • Creates and disperses various correspondences and reports that will be sent to the IRB members and/or investigators;
  • Conducts IRB file reviews insuring appropriate approval documents have been completed and filed appropriately;
  • Prepares and submits ongoing and new studies to Research and Development Committee;
  • Orients and educates investigators and coordinators as to proper protocol submission, and has the responsibility to explain the submission and review process to all current and future investigators; and
  • Performs related duties as assigned.

Work Schedule:?,Monday through Friday, 8:00am - 4:30pm.

REQUIRES: One year of specialized experience directly related to this position, which has equipped you with

the particular knowledge, skills, and abilities to successfully perform the duties of this position and that

is equivalent to at least the GS-06 level in the Federal service. Specialized experience includes: collect

and analyze data from diverse data sources for research protocol; use of statistical analysis to develop

useful reports for the purposes of benchmarking process efficiency; display that information in a variety of

formats for business process analytics and adapt analytical techniques and evaluation criteria to determine

program effectiveness; independently carry out the successive steps in reviewing, fact-finding and analysis

of issues necessary to complete each phase of research compliance prior to Institutional Review Board (IRB)

review; compile and evaluate information as part of a team effort including those related to the collections

and analysis of information; ensure comprehensive documentation regarding all data produced, etc. NOTE:

Experience must be detailed in your resume to receive full credit.

This position includes a Selective Placement Factor (skill, knowledge, ability or other worker characteristicbasic to - and essential for - satisfactory performance of the job). Selective Placement Factors are aprerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet itare ineligible for further consideration. This must be present on your resume assumptions will not be made. The Selective Placement Factor for this position is: Previous experience with Institutional Review Boards.

You will be rated on the following Knowledge, Skills, Abilities and Other characteristics (KSAOs) as part of the assessment questionnaire for this position:

  • Ability to review research proposals.
  • Knowledge of appropriate document protocols.
  • Ability to act as a liaison.
  • Skill in reviewing, documenting and tracking.
  • Knowledge of administrative duties.

PHYSICAL REQUIREMENTS: The work requires mobility and relative physical efforts may be required. Manual dexterity is required in operation of personal computer and other office equipment. The work is typically performed in an adequately lighted and climate controlled office.

For more information on these qualification standards, please visit the United States Office of Personnel Management"s website at http://www.opm.gov/qualifications.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).

Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

Veteran"s Preference: When applying for Federal jobs, eligible veterans should claim preference on the Occupational Questionnaire in the section provided and provide a legible copy of DD-214(s) showing all dates of service as well as character of service (honorable, general, etc.). Additionally, veterans with service-connected disability of 10% or more must also submit a copy of their official statement from the Department of Veterans Affairs, or from a branch of the Armed Forces, certifying their service-connected disability and/or their receipt of compensation for service-connected disability. If the military member is within 120 days of separation and does not yet have a DD214, the member may instead submit any written document from the armed forces that certifies the service member is 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 signed.

Veterans with service-connected disability of less than 10%, non service-connected disability, and Purple Heart recipients, as-well-as those claiming derived preference for a spouse, widow or widower, or natural mother, should refer to and submit a completed " SF15, "Application for 10-Point Veteran Preference," (go to http://www.opm.gov/forms/pdf_fill/SF15.pdf) and required documentation with your application materials. For more information on Veterans" Preference, please visit http://www.fedshirevets.gov/job/veterans.aspx.

The following documents are required:

  1. Resume
  2. Responses to the Occupational Questionnaire
  3. Other documents - use this?,checklist to make sure you have included other documents required for your application, such as a copy of your transcript (if using education to qualify), documentation to support Veterans Preference claims, or ICTAP/CTAP documentation (for displaced Federal employees). You will not be contacted for additional information.

Faxing Applications or Supporting Documents: You are encouraged to apply online. Applying online will allow you to review and track the status of your application. If you are unable to apply online or unable to upload your supporting documents to your online application, follow the directions located at the following site: Fax Options. The Vacancy ID of the job opportunity announcement is 1753666.

NOTE: If you applied online and your application is complete, do not fax the paper application (1203-FX) as this will overwrite your prior online responses and may result in you being found ineligible.


Keywords

REQUIRES: One year of specialized experience directly related to this position, which has equipped you with 

the particular knowledge, skills, and abilities to successfully perform the duties of this position and that 

is equivalent to at least the GS-06 level in the Federal service. Specialized experience includes: collect 

and analyze data from diverse data sources for research protocol; use of statistical analysis to develop 

useful reports for the purposes of benchmarking process efficiency; display that information in a variety of 

formats for business process analytics and adapt analytical techniques and evaluation criteria to determine 

program effectiveness; independently carry out the successive steps in reviewing, fact-finding and analysis 

of issues necessary to complete each phase of research compliance prior to Institutional Review Board (IRB) 

review; compile and evaluate information as part of a team effort including those related to the collections 

and analysis of information; ensure comprehensive documentation regarding all data produced, etc. NOTE: 

Experience must be detailed in your resume to receive full credit.

This position includes a Selective Placement Factor (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placement Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet it are ineligible for further consideration. This must be present on your resume assumptions will not be made. The Selective Placement Factor for this position is: Previous experience with Institutional Review Boards. 

You will be rated on the following Knowledge, Skills, Abilities and Other characteristics (KSAOs) as part of the assessment questionnaire for this position:

  • Ability to review research proposals.
  • Knowledge of appropriate document protocols.
  • Ability to act as a liaison.
  • Skill in reviewing, documenting and tracking.
  • Knowledge of administrative duties.

PHYSICAL REQUIREMENTS: The work requires mobility and relative physical efforts may be required. Manual dexterity is required in operation of personal computer and other office equipment. The work is typically performed in an adequately lighted and climate controlled office.

For more information on these qualification standards, please visit the United States Office of Personnel Management"s website at http://www.opm.gov/qualifications.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).

Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

About U.S. Department of Veterans Affairs

To be eligibile candidates must: 

  • have graduated with a baccalaureate degree from a school of professional nursing approved by the appropriate State-accrediting agency and accredited by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on Collegiate Nursing Education (CCNE). 

  • have successfully passed the NCLEX-RN exam and hold an active, unrestricted license by the start of the program, but have no RN experience. 

  • be able to work full time on day shift with preceptors and mentors.

  • sign a statement of commitment. 

  • have a minimum cumulative grade point average of 3.0.

  • Send cover letter & resume to Cynthia.Golden2@va.gov.

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