Research Protocol Specialist

Employer
USAJobs
Location
Fort Belvoir, Virginia
Posted
Jan 07, 2021
Closes
Jan 14, 2021
Function
Analyst, Research
Hours
Full Time
Duties

Summary

About the Position: This position is physically located in an office environment within a hospital. Hours of work will be standard business hours with some flexibility. A successful applicant can expect to play a vital role in the institution's Human Research Protections Program, ensuring human-subjects research protocols are conducted in compliance with DoD regulations, Federal laws, local policies, and consistent with the principles of Bioethics.

Telework could be authorized.
Learn more about this agency

Responsibilities

  • Orchestrates meetings with principal investigators and other research team members in order to identify submission requirements necessary for approval of research projects.
  • Coordinates the regulatory review process, including scientific review and IRB review.
  • Evaluates research protocols for compliance with applicable regulations governing human subject's protection, including 45 CFR 46, 32 CFR 219, DoDI 3216.02, and 10 USC 980 and HIPPA regulations.
  • Performs exempt research determinations with investigators and other designees to ensure Institutional Review Board (IRB) stipulations are appropriately addressed in a timely manner by providing knowledge and advice regarding regulatory requirements.
  • Provides consultation and assistance to complete research protocol lifecycle requirements e.g., continuing review applications, protocol amendments, study closure.


Travel Required

Not required

Supervisory status
No

Promotion Potential
None

Requirements

Conditions of Employment

  • This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Tier 3 security investigation or access for the duration of employment. A background investigation and credit check are required.
  • This position requires the incumbent to have tuberculosis testing.
  • Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.


Qualifications

Who May Apply: US Citizens

In order to qualify, you must meet the education and experience requirements described below. 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). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document .

Degree: 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.

Specialized Experience: One year of specialized experience which includes developing clinical research protocols; reviewing research protocols initial submissions and life cycle actions for compliance with regulations on human subject protection; identifying necessary resources for research; providing guidance on research ethics, and advising on issues related to human subjects research.This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service.

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted

It is HIGHLY preferred but not required that qualified candidates possess an active "Certified IRB (Institutional Review Board) Professional" (CIP) certification, have held the certification in the past, or be eligible to sit for the CIP exam.

You will be evaluated on the basis of your level of competency in the following areas:
  • Communications
  • Organizational Awareness
  • Technical Competence


Education

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html

Additional information

  • Male applicants born after December 31, 1959 must complete a Pre-Employment Certification Statement for Selective Service Registration.
  • You will be required to provide proof of U.S. Citizenship.
  • Two year trial/probationary period may be required.
  • Direct Deposit of Pay is required.
  • Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
  • If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the Reemployed Annuitant information sheet.
  • You may claim military spouse preference (MSP).
  • If a MSP applicant is determined best qualified and selected, placement must be at the full performance level for priority consideration.
  • Multiple positions may be filled from this announcement.
  • Salary includes applicable locality pay or Local Market Supplement.
  • Interagency Career Transition Assistance Program (ICTAP). If you are a Federal employee in the competitive service and your agency has notified you in writing that you are a displaced employee eligible for ICTAP consideration, you may receive selection priority for this position. To receive selection priority, you must: (1) meet ICTAP eligibility criteria (2) be rated well-qualified for the position and; (3) submit the appropriate documentation to support your ICTAP eligibility. To be considered well-qualified and receive selection priority applicants must satisfy all qualification requirements for the position and receive a score of 90 or above. Additional information about the program is on OPM's Career Transition Resources website.
  • 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 .
  • Payment of Permanent Change of Station (PCS) costs is not authorized, based on a determination that a PCS move is not in the Government interest.


How You Will Be Evaluated

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

Once the announcement has closed, a review of your application package (resume, supporting documents, and responses to the questionnaire) will be used to determine whether you meet the qualification requirements listed on this announcement. If you are minimally qualified, your résumé and supporting documentation will be compared against your responses to the assessment questionnaire to determine your level of experience. If, after reviewing your résumé and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully when applying, errors or omissions may affect your eligibility.

You should list any relevant performance appraisals and incentive awards in your resume as that information may be taken into consideration during the selection process. If selected, you may be required to provide supporting documentation.

Basis for Rating: Qualified candidates will be assigned to one of three quality categories: Best Qualified, Highly Qualified and Qualified. Veteran preference eligibles are listed ahead of non-preference eligibles within each quality category.
  • Best Qualified. Candidates in this category possess exceptional skills and experience to exceed well above the minimum requirements for the announced position.
  • Highly Qualified. Candidates in this category possess good skills and experience above the minimum requirements for the announced position.
  • Qualified. Candidates in this category meet the minimum experience requirements for the announced position.


Background checks and security clearance

Security clearance
Not Required

Drug test required
No

Required Documents

The documents you are required to submit vary based on whether or not you are eligible for preference in federal employment. A complete description of preference categories and the associated required documents is in the Applicant Checklist (External).

As described above, your complete application includes your resume, your responses to the online questionnaire, and documents which prove your eligibility to apply. If you fail to provide these documents, you will be marked as having an incomplete application package and you will not be considered any further.

1. Your resume:
  • Your resume may be submitted in any format and must support the specialized experience described in this announcement.
  • If your resume includes a photograph or other inappropriate material or content, it will not be used to make eligibility and qualification determinations and you may not be considered for this vacancy.
  • For qualifications determinations your resume must contain hours worked per week and the dates of employment (i.e., HRS per week and month/year to month/year or month/year to present). If your resume does not contain this information, your application may be marked as incomplete and you may not receive consideration for this position.
  • For additional information see: What to include in your resume .
2. Other supporting documents:
  • Cover Letter, optional
  • Most recent Performance Appraisal, if applicable
  • This position has an individual occupational requirement and/or allows for substitution of education for experience. If you meet this requirement based on education you MUST submit a copy of your transcript with your application package or you will be rated ineligible. See: Transcripts and Licenses

NOTE: Documents submitted as part of the application package, to include supplemental documents, may be shared beyond the Human Resources Office. Some supplemental documents such as military orders and marriage certificates may contain personal information for someone other than you. You may sanitize these documents to remove another person's personal information before you submit your application. You may be asked to provide an un-sanitized version of the documents if you are selected to confirm your eligibility.

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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