Research Protocol Specialist

Summary

About the Position: This position is located at Defense Health Network Pacific Rim, Naval Medical Center, San Diego, CA Directorate of Command (Staff Clinical Quality and Safety Clinical Investigations). Incumbent provides support to research investigator and research teams with knowledge of protocol development, regulatory compliance standards, Institutional Review Board (IRB) Administration, and human subjects research protections

Duties

• Reviews research protocols and consent documents for compliance and completeness.
• Advises investigators and staff on submission and regulatory requirements.
• Conducts post-approval compliance and quality-assurance reviews.
• Documents findings, deficiencies, and corrective actions.
• Coordinates with investigators and staff to resolve compliance issues.

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 which includes reviewing research or regulatory submissions for compliance, evaluating protocol documents, and identifying deficiencies. This definition of specialized experience is typical of work performed at the second lower grade/level position in the federal service (GS-07). 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, such as Master's degree in public Health (MPH), clinical/health research, or other relevant graduate degree. 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.

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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. How You Will Be Evaluated

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. Please follow all instructions carefully when applying, errors or omissions may affect your eligibility. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Veterans and Military Spouses will be considered along with all other candidates. Other 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.