Regulatory Specialist II

Company: The Johns Hopkins University
Location: Baltimore
Posted on: May 28, 2023

Job Description:

Press Tab to Move to Skip to Content Link We are seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. The Regulatory Specialist will serve as a central resource for faculty conducting clinical research in the Department of Radiology. Working closely with the Program Manager and Research Nurse, this position will complete and submit the initial IRB submission. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed. This position will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents.
Specific Duties & Responsibilities

• Work closely with the Research Nurse and PI on new studies to ensure timely, accurate submission to the IRB and sponsors.
• Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
• Obtain all required documents for new submissions to the IRB.
• Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
• Complete new study IRB submissions.
• Ensures smooth implementation of new trials from conception through study activation.
• Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening.
• For IND studies, maintain accurate and up-to-date documents and submissions.
• Collect all required documents from sites prior to study opening.
• Attend study start up meeting.
• Produce and maintain a regulatory binder prior to study starting with all required documents.
• Work closely with all sponsors to ensure all documents are reviewed, approved and correct prior to a study opening.
• Develop standard operating procedures as needed.
  
  Minimum Qualifications
  
  • Bachelor's Degree.
  • Requires minimum of 3 years of experience in academic or industry-based clinical research. Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research. Excellent verbal and communication skills are required.
  • Additional education may substitute for some experience, and additional directly related experience may substitute for some education.
    Classified Title: Regulatory Specialist II -
    Role/Level/Range: ACRP/03/MB
    Starting Salary Range: $ 40,100- 55,140- 70,180/Annually (Commensurate with experience) -
    Employee group: Full Time -
    Schedule: M-F 8:30-5:00 -
    Exempt Status: -Exempt -
    Location: School of Medicine Campus
    Department name: SOM Rad General Administration
    Personnel area: School of Medicine -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.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 EmployerAll 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
    Learn more:
    https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf Accommodation InformationIf 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 accessibility.jhu.edu .Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. 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. 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 on 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.Note: Job Postings are updated daily and remain online until filled. School of Medicine - East Baltimore Campus

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