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Job Req ID:  114125

Regulatory Specialist II

Under the supervision of the OCT Director, we are seeking a Regulatory Specialist II (RS) who will support investigator(s) and study team(s) in initiating studies. The RS will proactively engage with Principal Investigators (PIs) and their teams upon execution of Non-Disclosure Agreements/Confidentiality Disclosure Agreements (NDA/CDAs) to offer assistance with study start-up. Upon request, the RS will provide guidance to clinical research staff in preparing comprehensive study documents for submission to Institutional Review Boards (IRBs)/central Institutional Review Boards (cIRBs), the Clinical Research Contract team (CRC), Clinical Research Support Service team (CRSS), Investigational Drug Services (IDS), ancillary committees, and Sponsors/Contract Research Organizations (CROs). Acting as a central point of contact, the RS will ensure adherence to submission and approval timelines and facilitate communication with Sponsors/CROs and other stakeholders. Additionally, the RS will establish and maintain a tracking system to streamline the study start-up process and minimize delays. Operational support related to OnCore (JHM Clinical Trial Management System), including the eReg platform, and managing DocuSign requests will also fall within the RS's responsibilities.


If an Investigational New Drug/Device Exemption (IND/IDE) is necessary, the RS will collaborate closely with the Director for IDE/IND submissions for FDA clearance.

The role demands meticulous organization, keen oversight, a deep understanding of study start-up processes, and exceptional communication abilities.


Specific Duties & Responsibilities


Study Start-Up

  • Support investigator(s) and study team(s) with study start-up.
  •  Attend study start up meetings if requested.
  •  Create advertising, if appropriate.
  •  Ensure investigator(s) and study team(s) have completed required training.
  •  Prepare accurate IRB submissions and obtain timely IRB approval.
  •  Submit NDA, clinical trial agreement/contract, and budget approval for review and execution.
  •  Work closely with all OCT offices and pro-actively oversee study submissions.
  •  Ensure that eCRF, databases, and other essential study documents have been created.
  •  Create and/or review study-specific documents (i.e. case report forms) and other study-related materials and supplies.
  •  Assure all study documents are complete and consistent.
  •  Provide requested documents to Sponsor and/or CRO and assist Sponsor/CRO.
  •  Track study documents through the various offices during study start-up phase (from submission through approval) and ensure smooth implementation of new trials from conception through study activation.


Administrative Support

  • Develop and implement tracking systems to decrease delay in the study start-up process/activation.
  • The creation and maintenance of trackers is vital for monitoring various metrics related to study start-up to be able to evaluate real-time visibility into performance indicators.
  • Create essential Study Start-Up documents such as Checklists, Tip Sheets, and Q&A Documents, necessary for study start-up efficiency.
  • DocuSign Management: Responsibilities including managing DocuSign requests for electronic signatures, reviewing ICF templates, setting up users, and communication with staff and IRB.
  • Greenshire ClinCard, Offering assistance to clinical research teams seeking to utilize Greenshire ClinCard as a payment method for research participants.
  • Assist with the Office of Clinical Trials (OCT) website management.
  • Assist with Coordinating OCT activities such as the OCT Retreat and Clinical Trials Day.
  • Perform other duties as assigned.


Minimum Qualifications
  • Bachelor's Degree in related discipline.
  • A minimum of 3 years of experience in academic or industry-based clinical research.


Knowledge, Skills & Abilities

  • Excellent verbal and communication skills.
  • Excellent organizational skills.
  • Strong knowledge of GCP, ICH, OHRP, and local, State, & Federal regulations related to research with human subjects.
  • Familiar with Sponsor and FDA reporting requirements.
  • Experience with entering information in a Clinical Trial Management System.
  • Ability to simultaneously manage multiple projects, and effectively prioritize each.


Preferred Qualifications
  • Previous experience in the job function as research assistant, coordinator, or regulatory coordinator for commercially funded studies with a focus on human clinical research is preferred.
  • Strong knowledge of the regulatory requirements pertaining to the conduct and oversight of clinical trials.
  • Familiar with OnCore and DocuSign.

 

 

Classified Title: Regulatory Specialist II 
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: $40,900 - $71,600 Annually ($65,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30 am - 5:00 pm 
Exempt Status: Exempt 
Location: Remote 
Department name: SOM Admin Res Clinical Research Contract  
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.
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