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Research Compliance Monitor

Company Department of Defense
Location Fort Belvoir, VA
Update 8 Day ago
300
The Defense Health Agency, National Capital Region Medical Directorate (NCR-MD) is the future of Military Medicine- a partnership in World Class Medical Healthcare. The Walter Reed National Military Medical Center, the National Intrepid Center of Excellence (NICoE), Fort Belvoir Community Hospital, Dilorenzo Clinic and the Joint Pathology Center, provide world class medical services to the nation's service members and their families.

About the Position:
This position is located at Fort Belvoir Community Hospital within the Directorate for Education, Training, and Research, department of Research Programs clinical Investigation. The work is primarily sedentary and requires the use of a computer and other automated systems. Some light lifting may be required. Work aslo requires regular and recurring field visits, which involve long periods of standing and walking.

Who May Apply:
U.S. Citizens

Responsibilities

Within the Department of Research Programs you will plan and conduct random and for-cause monitoring/audits of human subjects research (exempt and non-exempt protocols) protocols at the Medical Treatment Facility (MTF) and outlining clinics for regulatory compliance. Create audit/monitor reports to be provided to the Institutional Review Board (IRB) of record and/or presented to Department of Research Programs leadership for review and determination of corrective action. You will develop and maintain an audit tracking system. Modify existing standard operating procedure and tools for the post approval compliance program. Conduct educational training with the MTF research community on current best practices and suggests corrective action plans. Create monthly productivity reports to provide to the Chief of Research Programs.

Travel Required

Not required

Supervisory status

No

Who May Apply

This job is open to…

U.S. Citizens

Questions? This job is open to 1 group.

Job family (Series)

0601 General Health Science

Requirements

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Requirements

Conditions of Employment

Other Requirements:
Click

here

for expanded definitions.

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.

Appointment is subject to the completion of a favorable suitability or fitness determination.

Direct Deposit of Pay is Required.

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.

This position has mandatory seasonal influenza vaccination requirements and is subject to annual seasonal influenza vaccinations unless otherwise exempted for medical or religious reasons (documentation of exemption must be provided upon hire).

Qualifications

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

.

Basic Requirement for Research Compliance Monitor:
Degree

: This position requires that you successfully complete a degree with a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position, such as Bioethics or Public Health from an accredited college or university. (NOTE: You must submit a copy of your transcripts with your application package)

In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:

Specialized Experience:
One year of specialized experience which includes applying human subject protection research regulations (e.g., Federal Common Rule, FDA, DoD) to ensure compliance; monitoring research studies for quality assurance; and utilizing electronic research submission/tracking systems such as electronic Institutional Review Board (IRB) management systems, IRBNet, MedIRIS, and InfoED. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (GS-11).

OR

Education:
Ph.D. or equivalent doctoral degree in a field which demonstrates the knowledge, skills, and abilities necessary to do the work of the position, such as: Bioethics or Public Health.

OR

Combination of Education and Experience:
A combination of education and experience may be used to qualify for this position as long as the computed percentage of the requirements is at least 100%. To compute the percentage of the requirements, divide your total months of experience by 12. Then divide the total number of completed graduate semester hours (or equivalent) beyond the second year (total graduate semester hours minus 36) by 18. Add the two percentages.

You will be evaluated on the basis of your level of competency in the following areas:

Communications

Compliance

Research

Training and Education Analysis

Education

Only degrees from an accredited college or university recognized by the Department of Education are acceptable to meet positive education requirements or to substitute education for experience. For additional information, please go to the Office of Personnel Management (OPM) and U.S. Department of Education websites at -

http://www.opm.gov/qualifications

and

http://www.ed.gov/admins/finaid/accred/index.html

.

Foreign education must be evaluated for U.S. equivalency in order to be considered for this position. Please submit your foreign education evaluation with your application.

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

.

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, see the information in the

Military Spouse Preference Under Delegated Examining Procedures

information sheet.

Multiple positions may be filled from this announcement.

How You Will Be Evaluated

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

Your application package

(resume, supporting documents, and responses to the questionnaire) will be used to determine your eligibility, qualifications, and quality ranking for this position. Please follow all instructions carefully. Errors or omissions may affect your rating or consideration for employment.

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.

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. See

Interagency Career Transition Assistance Program (ICTAP)

for more information. Additional information about the program is on

OPM's Career Transition Resources website

.

Background checks and security clearance

Security clearance

Not Applicable

Required Documents

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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.

Your resume:
Your resume may be submitted in any format.

If you submit more than one copy of your resume, only the most recent version will be reviewed. The latest timestamp will be used to determine which version of your resume is "most recent." It is your responsibility to check the status and timestamp of all documents you submit as part of your application.

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 will be marked as incomplete and you will not receive consideration for this position.

To meet the education requirement:
You MUST submit a copy of your transcript with your application package to meet the education requirement.

If you are relying on your education to meet qualification requirements:

You MUST submit a copy of your transcript if you want to substitute your education for experience. If you claim qualifications based on education, and do not submit a transcript, your education will not be used in making a qualification determination and you may be found "not qualified." See:

Transcripts and Licenses

License/Certification

: If the position has a license/certification requirement, you MUST submit a copy of your current, active, valid, unrestricted license/certification.

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.

Benefits

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Benefits

A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.

Benefits for federal employees

Healthcare insurance

Pay and leave

https://help.usajobs.gov/index.php/Pay_and_Benefits

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.