Regulatory Specialist II
Under general supervision from the Director, Office or Clinical Trials (OCT), the Regulatory Specialist II (RS) will assist investigators and study teams with study start-up. During the study start-up phase, the RS will prepare high quality study documents for submission to the IRB/cIRB, Office of Research Administration (ORA - commercial contract team), Clinical Research Support Service team (CRSS), Investigational Drug Services (Pharmacy/IDS), other ancillary committees, and sponsor. The RS will serve as a central resource for all parties involved and ensure that the study submission and approval timelines are met. In addition, the RS will liaise with the Sponsor/CRO and other entities.

If an IND/IDE is required, the RS will work closely with investigators, study teams and the Director, OCT for IDE/IND submissions on the submission to FDA.

The RS requires a high level of organization and oversight, strong knowledge of study start up process, and excellent communication skills.

Specific Duties & Responsibilities

• Work closely with the investigators and study teams to obtain required study documents.
• Ensure investigators and study teams 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.
• Respond in a timely manner to IRB, ORA, CRSS and other ancillary offices.
• Work closely with all OCT offices and pro-actively manage the study submission.
• 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.
• Review monitoring/auditing plans and ensure they meet regulatory requirements.
• Provide requested documents to Sponsor and/or CRO and assist Sponsor/CRO during study start-up phase of the study.
• Create the site regulatory binder/master file (Electronic Master Regulatory file).
• 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.
• Develop and implement systems to decrease delay in the study start-up process/activation.
• Attend study start up meetings as requested.
• Create advertising as appropriate.

Minimum Qualifications

• Bachelor's Degree in life sciences or related discipline required.
• Requires minimum of three (3) years of experience in academic, government or industry-based clinical research.
• Strong knowledge of the regulatory requirements pertaining to the conduct and oversight of clinical trials
  

• Strong knowledge of GCP, ICH, OHRP, and local, State, & Federal regulations related to research with human subjects
  

• Familiar with Sponsor and FDA reporting requirements.
  

• Knowledge of research methodology, clinical research practices, and principles required.
  
• Excellent verbal and communication skills.
  

• Excellent organizational skills.
  

• Must be a team player.
  

Preferred Qualifications

• OnCore experience preferred.

Classified Title: Regulatory Specialist II
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $40,100-$55,140 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5 pm
Exempt Status: Exempt
Location: Remote
Department name: ​​​​​​​SOM Admin Res Clinical Research Contract
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.

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
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.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 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.


To apply, visit https://jobs.jhu.edu/job/Baltimore-Regulatory-Specialist-II-MD-21205/963746100/








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