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The School of Medicine is seeking a Regulatory Specialist II for the Johns Hopkins Artificial Intelligence and Technology Collaboratory for Aging Research (JH AITC), which is a center designed to foster the development of novel uses of AI and technologies to improve the health and well-being of older adults. This position requires an autonomous person with regulatory experience in working with Institutional Review Boards and master/standard agreements.

Specific Duties & Responsibilities

• Work with JH AITC faculty and investigators from outside JHU to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements).

• Execute project management processes and methodologies to ensure AITC projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the AITC investigative teams by ensuring smooth implementation of new pilot projects from conception through study activation.

• Manage IRB submissions, tracking, and oversight for projects that require single IRB approval where an external site will rely on Johns Hopkins for regulatory approval.

• Prepare regulatory documents for Single IRB [sIRB] review.

• Work with participating sites to compile local context information for initial review, continuing review, protocol event reports and applicable changes in research to facilitate submission to the JHM IRB

• Assist the JHM IRB in contacting participating sites to address inquiries related to IRB review

• Train participating site leads on sIRB expectations/procedures

• Coordinate with JHM IRB leads to enhance sIRB processes for AITC-supported studies

• Develop work plans to achieve assigned project goals and organize all activities in support of project goals

• Complete and maintain professional documentation for projects and deliverables

• Obtain all required documents for new grant and protocol submissions

• Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delays in the approval process

• Draft consents

• Use professional judgment in handling information based on the situation and be sensitive to project team, individual and all levels of organizational concerns

• Ensure smooth implementation of new studies from conception through study activation

• Work closely with the project team and JH AITC Cores to ensure all documents are complete prior to study activation

• Develop SOWs as needed

• Collaborate with other project sites.

• Track proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators

• Serve a critical role as liaison and facilitate meetings between project stakeholders and AITC leadership and complete and maintain professional documentation for projects and deliverables, develop SOWs as needed, and assist the AITC personnel in the auditing and monitoring of studies.

• Assemble project plans, team and work assignments, directing and monitor work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.

• Make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making

• Help investigators develop new insights and understanding of performance-based data.

Minimum Qualifications

• Bachelor's Degree

• Requires minimum of three years of experience in academic or industry-based clinical research. Must have familiarity with OHRP, and federal regulations for human subject participation in clinical research.

• Additional education may substitute for some experience, and additional directly related experience may substitute for some education, to the extent permitted by the JHU equivalency formula

Preferred Qualifications

• Knowledge of FDA, ICH, and other regulatory guidelines, experience in writing research materials

• Experience with local and/or single IRB policies and submissions.

Classified Title: Regulatory Specialist II

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $41,300 - $72,300 Annually ($55,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F 8:30a - 5p

Exempt Status: Exempt

Location: Johns Hopkins Bayview

Department name: ​​​​​​​SOM DOM Bay Geriatric Medicine

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.