Johns Hopkins, founded in 1876, is America's first research

university and home to nine world-class academic divisions working

together as one university.

Under the supervision of the Accelerated Study Start-Up Program

Manager, we are seeking a Regulatory Specialist II

who will serve as a central resource for faculty conducting

clinical research. The Regulatory Specialist II will be assigned to

a dedicated portfolio of clinical divisions and their investigators

working to facilitate study startup and maintenance of commercially

sponsored clinical trials. Startup activities include coordination

of internal partners (study teams, central research administrative

teams) and external partners (commercial sponsors, CROs),

feasibility surveys, coordination and initiation of contract and

budget activities, and initial applications to the IRB and other

regulatory agencies. Maintenance activities include regulatory

activities over the duration of the study such as creating IRB

submissions such as change in research, continuing review, protocol

event report, etc., and managing required documents in the

electronic regulatory binder ensuring they are accurate and up to

date.

Specific Duties and Responsibilities

• Facilitate accelerated study startup activities including

feasibility surveys, coordination and initiation of contract and

budget activities, initial applications to the IRB and other

regulatory agencies, etc.

• Ensure smooth implementation of new trials from conception

through study activation.

• Monitor, track, and report critical study start-up milestones

e.g., IRB activities, processing and finalization of contracts,

drafting of a complete budget, etc.

• Communicate with, and track activities led by, internal and/or

external research team members and collaborators.

• Proactively monitor progress and remove barriers to study site

activation Serve as liaison between study teams and central

research administrative teams.

• Anticipate and mitigate risks to study start up.
• Assess feasibility and operational needs of new studies.
• Attend study startup meetings.
• Complete IRB submissions for new studies, obtaining documents

from the sponsor or creating all required documents as needed.

• Track each protocol through the IRB and subcommittee approval

process, evaluate for recurrent problems, develop and implement

systems to decrease delays in the approval process.

• Collect all required documents prior to study site activation

including investigator and personnel medical licenses, CVs, and

training documentation.

• Produce and maintain an electronic regulatory binder using

Advarra eReg to manage all required documents for the entire

duration of the study, ensuring they are accurate and up to

date.

• Create IRB submissions such as change in research, continuing

review, protocol event report, etc., as needed for the duration of

the study.

Minimum Qualifications

• Bachelor's Degree.
• Two years of experience in academic, government, or

industry-based clinical research.

• Familiarity with NIH, GCP, OHRP, and federal regulations for

human subject participation in clinical research.

• Additional education may substitute for required experience and

additional related experience may substitute for required education

beyond a high school diploma/graduation equivalent, to the extent

permitted by the JHU equivalency formula.

Preferred Qualifications

• One year of experience in a role responsible for study startup

activities in interventional clinical trials.

Classified Title: Regulatory Specialist II

Job Posting Title (Working Title): Regulatory Specialist II (Office

of Clinical Trials)

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $41,300 - $72,300 Annually ($60,000

targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F/37.5

FLSA Status: Exempt

Location: Remote

Department name: SOM Admin Res Clinical Research Contract

Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a

pre-employment background check.

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

HR Business Services Office at jhurecruitment@jhu.edu. For TTY

users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which

campus you will work. Your recruiter will advise

accordingly.

During the Influenza ("the flu") season, as a condition of

employment, The Johns Hopkins Institutions require all employees

who provide ongoing services to patients or work in patient care or

clinical care areas to have an annual influenza vaccination or

possess an approved medical or religious exception. Failure to meet

this requirement may result in termination of employment.

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.

Equal Opportunity Employer

Note: Job Postings are updated daily and remain online until

filled.

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