RESEARCH PROTOCOL SPECIALIST WITH SECURITY CLEARANCE
Department of Defense
San Diego CA 92101 US
Duties * 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. Requirements 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. * Mission Essential In the event of severe weather conditions or other such emergency type situations (natural or man-made disaster) the incumbent may be required to report to work or remain at work as scheduled to support mission operations. 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. 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). You will be evaluated on the basis of your level of competency in the following areas: * Compliance
* Computer Skills
* Customer ServiceEducation 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 * Candidates are expected to complete all requirements to be assigned as a BAMC Exemption Determination Official (EDO), responsible for reviewing and approving Research Not Involving Human Subjects (RNIHS) and HSR which is exempt from IRB review and providing not-research determinations. * PhD level expertise is preferred. * Previous clinical and/or research experience is preferred * 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. * Recruitment or relocation incentives 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 Review our benefits 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. 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. 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 Review our benefits * 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 eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies. The documents you are required to submit vary based on the authority you are using to apply (i.e., applying as a veteran, applying as a current permanent Federal employee, applying as a reinstatement, etc). Please review the following links to see which documents you need to provide to prove your eligibility to apply: Applicant Checklist for Internal/MP Announcements (DoD) 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 * Proof of Eligibility to Apply: Your application must include the documents which prove you are eligible to apply for the vacancy. The Proof of Eligibility document describes authorities commonly used in merit p
* Computer Skills
* Customer ServiceEducation 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 * Candidates are expected to complete all requirements to be assigned as a BAMC Exemption Determination Official (EDO), responsible for reviewing and approving Research Not Involving Human Subjects (RNIHS) and HSR which is exempt from IRB review and providing not-research determinations. * PhD level expertise is preferred. * Previous clinical and/or research experience is preferred * 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. * Recruitment or relocation incentives 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 Review our benefits 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. 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. 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 Review our benefits * 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 eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies. The documents you are required to submit vary based on the authority you are using to apply (i.e., applying as a veteran, applying as a current permanent Federal employee, applying as a reinstatement, etc). Please review the following links to see which documents you need to provide to prove your eligibility to apply: Applicant Checklist for Internal/MP Announcements (DoD) 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 * Proof of Eligibility to Apply: Your application must include the documents which prove you are eligible to apply for the vacancy. The Proof of Eligibility document describes authorities commonly used in merit p