The Office of Human Subjects Research is seeking a Biospecimen Program Administrator. The purpose of this position is to ensure that best practices are applied to the ethical acquisition, use, and distribution of human biospecimens by JHU researchers and their collaborators. Best practices include educational, operational, technical, ethical, legal, and policy approaches to facilitate the responsible stewardship of human biospecimens used for research purposes. This position includes the role of JHU Institutional Stem Cell Research Oversight (ISCRO) Administrator and provides support to the activities of the ISCRO and related activities of the JHU Institutional Review Boards (IRBs).

This position works closely with leadership across the Institution, including leaders from the Office of Research Administration (ORA), Johns Hopkins Technology Ventures (JHTV), Conflict of Interest Committee (COIC), HIPAA Privacy Office, the IRBs of the Johns Hopkins School of Public Health and Homewood Schools and other stakeholders (such as the ancillary committees engaged in the review of research with biospecimens, and the Animal Care and Use Committee). The Biospecimen Program Administrator also serves as a liaison for external entities for matters related to biospecimens in research.

Specific Duties & Responsibilities

• Provide leadership and vision for a centralized human biospecimen program at JHU.
• Oversee development and implementation of related policies, procedures and programs for a human biospecimen program in compliance with federal regulations, state laws and Institutional requirements.
• Provide direct support to the Biospecimen Transfer Committee (BTC) (to review and approve requests for use of human biospecimens obtained at JHU. The BTC will provide guidance for the acquisition, use, and transfer of human biospecimens for research, internal and external to JHU.
• Serve as a member of the BTC and perform expedited reviews.
• Work with the appropriate sponsored projects and contracting offices to facilitate the processes for Biospecimen Transfer Agreements.
• Oversee development and implementation of education and training programs for the research community related to responsible derivation, use and distribution of biospecimens, including human stem cell-related research.
• Develop and maintain registry of JHU ISCRO approved human embryonic stem cell lines to ensure timely and thorough review and approval of research protocols.
• Serve as a representative for JHU's Biospecimen Program to both internal and external stakeholders.
• Assist with the design, development and maintenance of electronic systems to support research with biospecimens, including but not limited to, eISCRO, eIRB, and any new tools needed to support the programs goals.
• Provide reports to Institutional Officials related to research activities involving human biospecimens, as needed.
• Maintain knowledge of current policy, guidance, and regulatory requirements related to human stem cell research and research with biospecimens (e.g., NAS, ISSCR, NIH, IRB, etc.) through continuing education, including attendance at related conferences.
• Facilitate the development and implementation of new policies and educational programs as they arise.
• Serve as the ISCRO Administrator, which includes the following responsibilities.
• In collaboration with the ISCRO Co-chairs, provide guidance to researchers at JHU working with human pluripotent stem cells.
• Serve as a liaison to the JHU IRBs for issues related to human pluripotent stem cells. Activities include select grant reviews, providing annual reports on ISCRO activities, assisting with review of applicable consent form language, and determinations regarding the need for ISCRO review.
• Investigate provenance information for human embryonic stem cell lines requested for use by researchers.
• Function as an alternate ISCRO member and conduct expedited reviews as designated.
• Identify compliance issues and report to ISCRO Co-chairs.
• Manage committee membership (orientation for new members, maintain roster, Bio sketches, membership renewals, attendance, and ensure payments to community members).
• Oversee the day-to-day activities of the Biospecimen Program Analyst in provision of administrative support to the Biospecimen Transfer Committee and the ISCRO Committee including scheduling of convened and expedited actions for Committee review, pre-screening applications to ensure they have sufficient information for review, preparing agendas, timely preparation of meeting minutes and issuance of determination letters.
• Maintains and updates the website for Human Stem Cell and Other Related Research and website content on the Office of Human Subjects Research website related to research with biospecimens.
• Other duties as assigned.

• Master's Degree in a related scientific, legal, or business field.
• Three years of related research and/or research ethics experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Knowledge of and familiarity with the regulatory agencies involved in human subjects research and pertinent laws and regulations and must have knowledge of related ethical considerations.
• Ability to apply regulatory requirements to proposed research protocols and have excellent oral and written skills.

Classified Title: Biospecimen Program Administrator   
Role/Level/Range: ATP/04/PE  
Starting Salary Range: $73,300 - $128,300 Annually ($95,000 targeted; Commensurate w/exp.) 
Employee group: Full Time 
Schedule: Monday - Friday 8:30am - 5:00pm 
FLSA Status: Exempt 
Location: Remote 
Department name: SOM Admin Clinical Invest Human Subjects   
Personnel area: School of Medicine