Job Title: IRB Professional for Human Research
Hyperion Biotechnology is looking for a highly qualified Expert Analyst for human research in Falls Church, VA.
1) Bachelor’s degree with 6 years of specialized experience or Graduate degree with 4 years of specialized experience. (Examples of specialized experience include, but are not limited to, reviewing, providing guidance on, and writing human research protection policy (HRPP), auditing compliance of HRPPs, researching and/or analyzing HRPP-related problem, issues or program requirements, research and/or analyzing complex HRPP issues, reviewing information, applying various analytical techniques, and developing recommendations and proposals related to HRPP program administration, extracting and assembling information, conducting analysis, and developing reports or presentation related to HRPP training, policy, guidance, and IRB issues, and reviewing protocols to ensure compliance with applicable HRPP requirements.)
1) Provide expert guidance and support in all matters related to the Air Force (AF) Human Research Protection Program (HRPP) via the AF Research Oversight and Compliance Office. This requires considerable judgment and discretion in determining and interpreting the intent of and AF conformance to legislation, regulations, policies, directives, guidance and established precedent.
2) Perform detailed review of potential human research activities for the AF HRPP.
3) Provide written and verbal analysis addressing human research protection requirements, working closely with the Research Oversight and Compliance Chief, other subject matter experts, and other internal and external customers as needed
4) Coordinate review of human research protocols by the Surgeon General’s Human & Animal Research Panel (SGHARP), as required. Ensure compliance of activities with AF policy on Assurances and DoD Addendums
5) Review, provide corrective guidance to submitters, and otherwise coordinate submission of applications for AF issued DoD Assurances, AF issued Addendums to the Federalwide Assurance, and related documentation (e.g., HRPP policies and procedures) from initial receipt through the final disposition.
6) Draft and provide senior technical support for the update and preparation of AF, multi-service, and joint policy guidance and other official publications, based upon AF HRPP policy and/or guidance from leadership. Make pertinent change recommendations regarding existing AF policy and guidance, as appropriate to the task/s. Draft new policies under oversight of leadership. Assist in the development of internal operating procedures for the AF HRPP, and, upon request or as necessary, for local AF HRPPs.
7) Provide HRP education and training for the AF HRPP as needed and in consultation with leadership. Prepare and present reports, PowerPoint presentations, and other items needed to provide ongoing HRPP education and training (e.g. at conferences). Arrange necessary logistics related to this task.
8) Monitor compliance of the AF HRPP. Monitor and track approved Assurances, Addendums, and related documentation to ensure ongoing compliance (e.g. confirm existing Institutional Agreements for Institutional Review Board (IRB) Review with IRBs of record) and to ensure timely receipt of requests for renewal or proper termination. Coordinate continuing oversight of ongoing research under AF-issued DoD Assurances. Monitor and track submissions or required follow up documentation (e.g. continuing reviews). Monitor protocol amendments, progress reports and other related documentation to ensure continuing compliance and protection of human research subjects.
9) Plan logistics of staff assistance visits (SAVs) to sites with AF-issued DoD Assurances or DoD Addendums to evaluate HRPPs, evaluate compliance of AF supported or conducted research. Participate in SAVs with leadership personnel and provide any needed support. Draft SAV-related letters (e.g. announcement and finding letters), tracks site compliance with SAV requests for documentation, perform expert review of related materials in preparation for SAV, advise senior leadership personnel regarding compliance issues identified and best practice recommendations, During SAVs, assist/resolve HRPP issues related to local implementation of the AF HRPP.
10) Exercise superior written and verbal communication skills, as well as public relations skills, in communicating with internal AF personnel and external non-AF personnel.
11) Establish and maintain contact with local HRPPs, which may be AF, other DoD, or civilian, for the purpose of maintaining oversight, exchanging information and reporting progress or problems associated with local implementation of the AF HRPP or any AF human research conducted or supported by the Institution. Provide advice to investigators, HRPP personnel and others on regulations, policies, procedures, guidance, and operations in support of the AF HRPP. Work with personnel to resolve issues relating to the AF HRPP (e.g. protocols or local HRPP policies and procedures).
12) Coordinate preparation for and attend meetings, conferences, demonstrations and other events. Prepare minutes on events attended for general distribution.
13) Along with senior DoD HRPP representatives, participate in DoD working groups, citing existing AF policy and seeking guidance from leadership on other issues as needed.
14) Update protocol and Assurance databases, as needed.
15) Provide responsive quick reaction analysis, briefing or precedent.
16) Prepare monthly status report on work accomplished for submission to AFMSA/SGE-C and the COR
17) Other duties necessary to support the performance of duties described.
To Apply: Please submit your resume / CV through this website only! No phone calls. Include your availability, citizenship or visa status, desired salary, and references.
Hyperion Biotechnology does not discriminate in hiring on the basis of race, national origin, color, creed, religion, sex, age, disability, veteran status, sexual orientation, gender identity, or associational preference.