Provides subject matter expertise related to federal, state, Department of Defense (DoD) and Department of Navy (DoN) policies governing research ethics, Human Subjects Research (HSR), and Human Research Protection Program (HRPP) to support the United States Naval Academy (USNA).
Maintains the local USNA instruction and manual that describes the Naval Academy's policies and procedures for the USNA Human Research Protection Program (HRPP).
Drafts, coordinates approval and disseminate relevant HRPP related USNA notices.
Develops standard operating procedures (SOPs) and guidance to implement and augment USNA HRPP policies.
Maintains documentation in the office that includes a list of and information about each SOP, including hard and electronic copies of each current SOP, its date of approval and implementation, its expiration/update information, and a log /database of all modifications made to each approved SOP.
Reviews literature on research ethics and human research protection programs weekly to remain current. Maintain a library in the HRPP Office of the relevant literature, available for reference, review and borrowing by USNA faculty and staff.
Ensures USNA instructions, notices, procedures and policies conform to and remain current with federal regulations, state and local laws , as well as with current SECNAV instructions and directives ( e.g., SECNAVINST 3900.39D)
Tracks the USNA DON Assurance for expiration, currency, and re-issue.
Reviews and maintains the Academy's IRB registration records associated with the USNA DON Assurance. Develop and provide all required and requested Assurance review reports (including, but not limited to, status of the assurance, corrective actions and recommendations) that can be shared with USNA leadership.
Provides advice to the USNA administration regarding the U.S. Naval Academy HRPP Office and implementation of the Human Research Protection Program throughout USNA and at the Naval Academy Preparatory School (NAPS) in Rhode Island.
Assists faculty, staff and midshipmen at USNA and faculty, staff and students at NAPS with the development and preparation of complete research protocol packages, for submission to the USNA HRPP Office.
Coordinates scheduling and provide administrative support for at least four formal meetings per year of the Academy's IRB to review USNA research protocols.
Prepares and submits reviewed protocol packages to the Superintendent for review and his approve/disapprove decision.
Prepares for submission all reports and records required to be forwarded to Senior Navy Leadership, to the DON-HRPP office at BUMED, and elsewhere concerning the protection of human subjects involved in research at the Naval Academy and/or NAPS.
Prepares required reports to USNA leadership concerning the HRPP office and the reviews of protocol submissions.
Develops and maintain monthly status reports that describe the activities of the USNA HRPP office and the Academy's IRB during the previous month (including, but not limited to: details of protocols received and their disposition; work undertaken and completed; activities and meetings of the Academy's IRB; training sessions offered; etc.) Provide these required monthly reports to the COR on this contract, via the contractor's contract manager.
Reviews all incoming HRPP related correspondence addressed to USNA, including e-mails and hardcopy, from all Navy and non-Navy activities, determine action required, and track actions to completion using an electronic database system.
Tracks all requests for action or information received by the USNA HRPP office from within the Academy or from Navy leadership. Serve as liaison with persons or groups within and outside USNA to staff responses to such requests.
Drafts and/or edits all memoranda, correspondence, action packages, documents, reports, and presentations for the USNA HRPP Office.
Maintains, and expands as warranted, the HRPP training program at USNA and at NAPS.
Provides training (such as through presentations, workshops, posters, social media, etc.) on human research protection topics to include (but not limited to): command leadership, research leadership, the Academy's Institutional Review Board (IRB), research personnel, medical staff, faculty, staff and midshipmen of the USNA, and faculty, staff and students at NAPS.
Develops USNA specific training materials, courses and presentations that augment generalized HRPP training provided by higher authority. Maintain documentation in the office via a spreadsheet database of each training presentation that includes audience type, approximate number of attendees, date and location, and media used. Maintain copies (hard and electronic, as appropriate) of each presentation.
Develops and maintain an active training program for faculty, staff and midshipmen conducting or participating in research programs at the USNA and/or at NAPS.
Develops feedback and assessment reports on the effectiveness of the training received.
Maintains all Collaborative Institutional Training Initiative (CITI) certification records for HSR investigators and for all USNA personnel required to complete the CITI modules.
Develops information and postings for the USNA HRPP websites, including a list and brief summary description of education and training articles, presentations and references. Develop and maintain a state-of-the-art web-based system for the submission of the components of a research protocol.
Interacts on a regular basis (and more often, as needs dictate) with the HRPP website webmaster (as identified by USNA) to maintain, update and expand documents, links and information on the Academy's HRPP websites. Monitor the Academy's HRPP websites for currency and accuracy of information, broken links, etc.
Writes updates, summaries, articles, etc., on current human research protection programs as they apply to USNA personnel for publication in USNA newsletters, on web sites, etc.
Other Job Requirements
Responsibilities
Documented direct, recent work experience in human subject research protection within and/or with DoD-HRPP. Well-versed in applied research ethics, and knowledgeable in the regulations applicable to social and behavioral human subject research.Experience with data and records management, specially related to HRPP programs.Knowledge of HRPP programs; especially within a DoD or DoN environment preferred.Current in professional training and certifications (SRAI and PRIMR).Excellent written and verbal communication skills.Excellent word processing, spreadsheet and database skills.Independently proficient in the use of computer hardware/software.Highly organized, with an efficient work ethic and professional approach to the position and responsibilities.
General Job Information
Title
Subject Matter Expert Mid-Level, HRRP
Grade
21
Work Experience - Required
Research
Work Experience - Preferred
Education - Required
High School
Education - Preferred
License and Certifications - Required
HRP - Human Research Protections Certification (SRA) - Enterprise, HSR - Human Subjects Research Certificate - Enterprise
License and Certifications - Preferred
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