Research Administrator with Security Clearance

Duties * Advise researchers and support staff on how to remain in compliance with the guidelines and regulations. * Coordinate initial review of protocols with investigators and notify investigators regarding administrative and protocol requirements. * Process requests from physicians for the one-time use of an investigative new drug or device. * Coordinate preparation, review, and distribution of meeting agendas, minutes, and pertinent protocol documents. * Maintain current references on all legislation, regulations, and technical policy advances affecting the review of research and apply knowledge of the same on a daily basis. * Perform audits of protocol files, providing the administrative and technical insight into requirements of policies, regulations, and laws governing research. * Ensure that forms adequately document current study activity and regulatory criteria. * Ensure that checklists prompt reviewers to document consideration of regulatory and ethical criteria for the initial or continuing approval of human subject research. * Coordinate initial review of animal protocols with investigators and the attending veterinarian. * Ensure that forms adequately document current study activity and regulatory criteria, such as inclusion of pain categories and literature searches for alternate means. Requirements Conditions of Employment * This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Secret security clearance or access for the duration of employment. A background investigation and credit check are required. * This position has been designated Mission Essential. In the event of severe weather conditions or other such emergency type situations, the incumbent is required to report to work or remain at work as scheduled to support mission operations. * You may be required to travel up to 5% of the time. * You may be authorized to Telework on a Regular and Recurring or Situational basis. 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 coordinating and analyzing with personnel on clinical medical research projects; and interpreting and maintaining all documentation from research projects to include preparation, monitoring, and submission of research protocols, policies, and/or procedures. This specialized experience is equivalent to the GS-9 grade level in the Federal service. OR Education: Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. OR Combination of Education and Experience: Specialized experience as described above, but less than one year; and at least two years of graduate education as described above, but less than the required three years. Compute the percentage of the requirements that met, and the total is at least 100% (To compute the percentage, divide your total months of qualifying experience by 12. Then, divide your semester hours of graduate education beyond the second year (total graduate semester hours minus 36) by 18. Add the two percentages. The total percentage must equal at least 100 percent to qualify.). (Note: You must attach a copy of your transcripts.) You will be evaluated on the basis of your level of competency in the following areas: * Administration and Management
* Compliance
* Manages and Organizes Information
* Oral CommunicationEducation 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/ . 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. * One 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. * Advanced in Hire and Advanced leave accrual MAY be authorized for highly qualified candidates. * 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. * Benefits Help 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 window Learn more about federal benefits . Review our 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. 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 resume and supporting documentation will be compared against your responses to the assessment questionnaire to determine your level of experience. 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. 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. You may claim Military Spouse preference. Military Spouse Preference (MSP) applicants will receive preference consideration and will be placed (if selected) at the highest grade for which they have applied and are determined best qualified, up to and including the full performance level. You may claim Priority Placement Program (PPP) preference. DoD Priority Placement Program (PPP) Applicants will receive preference consideration at the full-performance grade level only. 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. * Benefits Help 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 window Learn more about federal benefits . Review our 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. * Required Documents As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligibl