IRB Compliance Analyst

Employer
USAJobs
Location
Montgomery County, Maryland
Posted
Sep 17, 2019
Closes
Sep 24, 2019
Function
Analyst, IT, QA Engineer
Hours
Full Time
Duties

Summary

The ideal candidate will be a skilled research professional and will have experience in assessment of non-compliance or unanticipated problems occurring during the conduct of human subjects research, and the ability to determine if there are immediate safety concerns and act accordingly. They will also have first-hand knowledge of good clinical practice, and methodologies to analyze and resolve complex or sensitive problems related to the conduct of clinical trials.
Learn more about this agency

Responsibilities

  • Serves as the primary contact regarding IRB procedures and regulatory requirements for reporting events such as non-compliance and unanticipated problems which occur in research conducted in the IRP.
  • Reviews reports of deviations, non-compliance and unanticipated problems submitted by investigators to the IRB for compliance with regulatory, policy, and procedural requirements and for completeness, appropriateness, and adequacy of information provided.
  • Assists individuals and groups in defining problems, identifying available internal and external education resources, and selecting educational options to support continual learning and advancement of clinical expertise.
  • Develops and conducts educational activities to include conferences, rounds, training, and seminars for IRB staff and Principal Investigators to help intramural researchers acquire, maintain, or increase their competence in protection of human subjects and good clinical practice in clinical trials.
  • Instructs and advises protocol development and management staff members regarding questions about protection of human subjects that may arise during protocol planning and implementation and assists them with analyzing related regulatory issues.
  • Participates in educational activities for IRB professionals and pursues Certified IRB Professional (CIP) certification and continuing education.


Travel Required

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

Supervisory status
No

Promotion Potential
13

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.
  • 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.
  • Position requires Education.


Qualifications

You must meet the following qualification requirements:

Basic Position Requirements
You must possess a degree in a major study in an academic field related to the health sciences, medical field or allied sciences appropriate to the work of the position.

AND
Requirements for Applicants to the GS-12 level:

You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: conducting training initiatives within a human subjects research protections program (HRPP) with individual and/or small or large groups of investigators; assisting individuals and groups within an HRPP at all levels of experience in defining educational needs related to conduct of human subjects research; selecting appropriate educational formats to support the HRPP community in its efforts to advance clinical research that is compliant with regulatory requirements; identifying possible concerns as related to noncompliance with protocol or institutional policy requirements.

Requirements for Applicants to the GS-13 level:
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: developing and conducting training initiatives within a human subjects research protections program (HRPP) such as educational tools, sessions or seminars; assisting individuals and groups at all levels of experience in defining educational needs related to conduct of human subjects research; identifying available internal and external informational resources and selecting educational formats to support the HRPP community in its efforts to advance clinical research that is compliant with regulatory requirements; identifying noncompliance with protocol or institutional policy requirements.

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/10498522

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 " non-emergency/teleworker " employee. In the event of a closure, you must be available to telework or request leave.
  • At the supervisor's discretion, this position may offer work schedule flexibilities : [telework, remote work, compressed schedules, flexible schedules].
  • 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.


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

Security clearance
Other

Drug test required
No

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

Trust determination process
Credentialing

Required Documents

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 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 Center , and the USAJOBS Resume Writing Video Tutorial .

    Assessment Questionnaire:

    You must submit a completed assessment questionnaire.

    Eligibility Documentation:

    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 required documents and information.
    • - Visit our sites on Career Transition Assistance Program (CTAP) / Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation .
    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.

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