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We are seeking a **_Director OHSR Operations_** for the SOM Office of Human Subjects Research (OHSR) has primary responsibility for designing and implementing the strategic operational goals of the OHSR. This role ensures that OHSR processes and procedures are managed efficiently and effectively. As an active member of the OHSR leadership team, the Director will work closely with the Vice Dean for Clinical Investigation, the Associate Dean for Human Research Protections and Director of the Human Research Protections Program, Institutional Review Board (IRB) Chairs, OHSR Director of Compliance and leaders from the Research Environment Systems (RES), Office of Research Administration (ORA), Office of Outside Interests (OOI), HIPAA Privacy Office, and other IRB ancillary committees.

Specific Duties & Responsibilities

+ Set strategic goals for operational efficiency and increased effectiveness of the OHSR. Identify areas for improvement and develop approaches to meet strategic goals. Manage key members of the OHSR Operations staff including the Training Manager, Senior Systems Administrator and Budget Analyst.

+ Work with JH IT and RES leadership on the evaluation of products to replace the current electronic application submission system. In close collaboration with RES, lead the development, testing and implementation of a system for application submission and management.

+ Monitor the electronic process for submitting applications for IRB and ancillary reviews and offer solutions to address system inefficiencies. Investigate system performance issues and work with developers to create solutions.

+ Responsible for on-going planning of programs and processes to assess the level of knowledge, performance, and work productivity of the operations management and staff.

+ Take a lead role in planning the OHSR staff retreat and other OHSR annual activities including the IRB member and JHM Human Research Protection Program (HRPP) retreat.

+ Responsible for evaluating the OHSR operational effectiveness and continually refining the structure, policy, and processes to meet required outcomes.

+ Oversee the system for billing review fees and implement solutions for improvement where necessary.

+ Participate in the management of budgets and financial resources to ensure expenditures align with organizational goals. Develop cost-effective strategies to optimize spending without compromising the quality of the operation.

+ Develop and implement strategies and programs to improve staff engagement and monitor progress through assessment of Glint survey and internal staff survey results.

+ As an alternate IRB member, review and approve expedited/exempt/NHSR and planning phase applications.

+ Monitor and approve requests for various access levels to the eIRB system.

+ Assume a lead role in the accreditation renewal process with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

+ Assume a lead role in US Food and Drug Administration IRB inspection visits and Office of Human Research Protection (OHRP) audits.

+ Other duties as assigned.

Minimum Qualifications

+ Bachelor’s Degree.

+ Seven years of experience relevant to the planning, conduct or administration of human subject's research.

+ Supervisory or lead 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.

Preferred Qualifications

+ Experience in the management of an IRB or Human Research Protection Program.

+ Experience in supervision and development of staff in an academic environment.

+ Experience with development and management of electronic research and/or project tracking systems.

+ Current CIP certification.

Classified Title: Director, OHSR

Job Posting Title (Working Title): Director OHSR Operations (Office of Human Subjects Research)

Role/Level/Range: L/04/LE

Starting Salary Range: $86,300 - $151,000 Annually (120,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Monday - Friday 8:30am - 5:00pm

FLSA Status: Exempt

Department name: SOM Admin Clinical Invest Human Subjects

Personnel area: School of Medicine

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.