About the Position: This position is a Research Administration Program Analyst located with the Clinical Investigations Department at Naval Medical Center, San Diego in California. A recruitment or relocation incentive may be authorized. Salary negotiation may be available for those candidates who are new to Federal service. Student Loan repayment may be authorized. Non-Federal work experience may be creditable for leave purposes.

Duties

Support investigators who are submitting research proposals for review by the Institutional Review Board to conduct Human Subjects Research. Responsible for all facets of research administration at NMCSD. The activities of research administration are complex and guided by federal regulations and policies. Should have proficient knowledge regarding human subject research protections, how to apply ethical principles pertaining to the concept of human subject research and working knowledge of the federal regulations pertaining to IRB operations. Should be knowledgeable of regulations and principals pertaining to: -Informed consent process, consent elements and requirements, HIPAA waivers and authorizations and Conflict of Interest. - Subject Compensation and Certificates of Confidentiality. - Working with collaborating institutions, extending an FWA to cover collaborating institutions or investigators, and IRB reliance agreements. - Ensuring appropriate Risk vs benefit ratio, Pediatric Research, FDA Clinical Trials and Phase I-IV Clinical Trials. - Subject population, subject recruitment and advertisements, subject exclusion and inclusion criteria, Vulnerable populations, and 45 CFR 46. - Revised Common Rule, IRB Review categories, Greater than Minimal Risk, Minimal risk, and Exempt categories.

Requirements

• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
• 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.
• Selectees will be required to sign a statement (Condition of Employment) consenting to seasonal influenza vaccinations or must provide a recognized exemption.

Qualifications

Who May Apply: Only applicants who meet one of the employment authority categories below are eligible to apply for this job. You will be asked to identify which category or categories you meet, and to provide documents which prove you meet the category or categories you selected. 30 Percent or More Disabled VeteransCurrent Civilian Employees of the Defense Health Agency (DHA)Current Permanent Department of Defense (DoD) Civilian EmployeeDomestic Defense Industrial Base/Major Range and Test Facilities Base Civilian Personnel WorkforceExecutive Order (E.O.) 12721Interagency Career Transition Assistance PlanLand Management Workforce Flexibility ActMilitary Spouses, under Executive Order (E.O.) 13473Non-Appropriated Fund Instrumentality (NAFI)Non-Department of Defense (DoD) TransferOffice of Personnel Management (OPM) Interchange Agreement EligiblePeople with Disabilities, Schedule APriority Placement Program, DoD Military Reserve (MR) and National Guard (NG) Technician EligiblePriority Placement Program, DoD Military Spouse Preference (MSP) EligiblePriority Placement Program, DoD MR and NG Preference Eligible Tech Receiving Disability RetirementPriority Placement Program, DoD Retained Grade Preference EligibleReinstatementVeterans Employment Opportunity Act (VEOA) of 1998Veterans Recruitment Appointment (VRA) 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 researching regulatory guidance for application to clinical research projects; preparing clinical research documentation that aligns with regulatory and principal guidance such as cooperative research and development agreements (CRADA), enter service support agreements (ISA), memorandum of agreement (MOA), memorandum of understanding (MOU), project assurances (Single, Cooperative, and Multiple); and providing guidance or training to personnel regarding various regulations and policy applicable to the clinical research process. This definition of specialized experience is typical of work performed at the second lower grade/level position in the federal service (GS-09). OR Education: Ph.D or equivalent doctoral degree or 3 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. 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: Customer Service (Clerical/Technical)Problem SolvingTechnical CompetenceWritten Communication Time in Grade Requirement: Applicants who have held a General Schedule (GS) position within the last 52 weeks must have 52 weeks of Federal service at the next lower grade or equivalent (GS-09).

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.

Contacts

• Address JT-DHA-DD83DZ DHA SAN DIEGO MARKET DO NOT USE San Diego, CA 92134 US
• Name: Army Applicant Help Desk