The Office of Human Subjects Research is seeking a Biospecimen Program Administrator. This fully remote position operates through the Johns Hopkins Medicine Human Research Protection Program (JHM HRPP) and has primary responsibility for oversight and management of the Biospecimen Program at Johns Hopkins University.
The purpose of the Biospecimen Program 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).
In this role, the Biospecimen Program Administrator reports to the Associate Dean for Human Research Protection and Director of the Human Research Protection Program, as well as the Vice Deans for Clinical Investigation and Research. 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.
This position has been designated as a 100% remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.
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 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 JHUs 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 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.
Special Knowledge, Skills & Abilities
Excellent organizational and interpersonal skills required.
Ability to work independently and exercise judgment.
Must have strong oral and written communication skills.
Must be a team player.
Ability to work in fast paced and demanding environment and able to manage multiple tasks effectively.
Must have demonstrated leadership, management, operations and problem-solving skills.
Must have demonstrated ability to work effectively with other Institutional entities within the HRPP and others who have responsibilities regarding the ethical conduct of research.
Must be familiar with the regulatory agencies with oversight responsibilities regarding research and be conversant with ethical considerations related to that subject.
Must have working knowledge of the applicable regulations related to human subjects research, HIPAA privacy, good clinical practice, and research with biospecimens, including applicable NIH policies, and national and international guidelines for stem cell research.
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Communication skills using the spoken word.
Willingness and ability to travel to other institutions to represent Johns Hopkins University and to obtain information contributing to Best Practices.
Ability to see within normal parameters.
Ability to hear within normal range.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Masters Degree in an appropriate scientific, legal or business discipline, (e.g., M.S., M.B.A., M.H.A.) is required.
Minimum of 3 years of experience related to research and research ethics.
Prior experience with research with biospecimens and/or human subjects research preferred.
Prior supervisory experience preferred.
Prior experience in education/teaching is desirable.
Classified Title: Biospecimen Program Administrator Role/Level/Range: ATP/04/PE Starting Salary Range: $71,230-$97,880-$124,510 Annually (Commensurate with experience) Employee group: Full Time Schedule: Monday - Friday 8:30am - 5:00 pm Exempt Status: Exempt Location: Remote Department name: SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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