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Requisition ID:  117146

Regulatory Specialist II

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 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. 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/.

Education and Experience Equivalency
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 Completing Studies
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.

Background Checks
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.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

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.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
Johns Hopkins Bayview

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