Job Description

Summary

About the Position: This position is located at Brooke Army Medical Center, San Antonio, Texas.

This is a Direct Hire Solicitation

Salary negotiation may be available for those candidates who are new to Federal service.

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Duties

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• Protect human subjects by advising prospective investigators on complex requirements for protocol development.
• Review draft protocol submitted by investigators to ensure it complies with federal regulations.
• Summarize detailed minutes of each meeting in accordance with written requirements for Institutional Review Board proceedings.
• Maintain protocol files with all required documentation in accordance with federal regulations.
• Answer inquiries from prospective investigators to assist them in meeting all requirements.
• Direct complex medical research questions to the appropriate consultant.
• Serve as administrative coordinator for the Institutional Review Board.
• Review draft protocols, informed consent forms, HIPPA documents, and corresponding submission documents submitted by investigators to ensure it complies with federal regulations.
• Establishprotocol files with all the required documentation on new submissions, revisions, adverse events, continuing reviews, consent forms, and HIPAA documents in accordance with all Federal regulations.
• Manage the administrative review of the protocol life cycle actions.

Requirements

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Conditions of employment

• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
• A Personnel Security Investigation is required.
• Selectees will be required to sign a statement (Condition of Employment) consenting to seasonal influenza vaccinations or must provide a recognized exemption.
• Immunization screening is required. Hepatitis B immunization is required for all positions with direct patient contact. Applicants may be required to show proof of other immunizations depending on the type of position.

Qualifications

Who May Apply: US Citizens

In order to qualify, you must meet the education and/or 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.

Specialized Experience: One year of specialized experience equivalent to the GS-07 grade level in the Federal service which includes coordinating with various clinical investigation departments, research committees and investigators; utilizing protocol development; reviewing clinical research protocols; interpreting federal regulations used for human research subjects and experience working with clinical research protocol record maintenance, and working with an electronic submission system for research protocols such as eIRB.

OR

Education: Master's or equivalent graduate degree or 2 full years of progressively higher-level graduate education leading to such a degree in a field which demonstrates the knowledge, skills, and abilities necessary to do the work of the position. (NOTE: You must attach a copy of your transcripts for verification).

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 first year (total graduate semester hours minus 18) by 18. Add the two percentages. (NOTE: You must attach a copy of your transcripts for verification).

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: .

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.
• This position requires a 1 year probationary period during which the agency evaluates your fitness and whether your continued employment advances the public interest. In making this determination, the agency may consider your performance and conduct; agency needs and interests; whether your continued employment supports organizational or Government goals; and whether it promotes the efficiency of the Federal service. Continued employment requires written certification that it advances the public interest.
• Direct Deposit of Pay is required.
• Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
• Multiple positions may be filled from this announcement.
• Salary includes applicable locality pay or Local Market Supplement.
• 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.
• 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.
• Position is designated as Mission Essential. The incumbent will be required to report to work during times of contingency operations, natural disasters, extreme weather or other emergency situations.

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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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. Opens in a new windowLearn more about federal benefits.

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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.

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