Regulatory Specialist II (Oncology)

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

university and home to nine world-class academic divisions working

together as one university.

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. This role will serve as a

central resource for faculty conducting clinical research.

Specific Duties & Responsibilities

• Collaborate with the Research Nurse and/or Principal

Investigator to ensure timely and accurate submissions to the IRB

and study sponsors.

• Obtain and prepare all required documents for new IRB

submissions, including initial study submissions.

• Oversee the smooth implementation of new clinical trials from

study conception through activation.

• Coordinate with the protocol compliance team to ensure

readiness of regulatory documents prior to study initiation.

• Collect all required regulatory documents from participating

sites when JHU/JHM serves as the coordinating center, ensuring

timely collection

• Develop and maintain standard operating procedures (SOPs).
• Support auditing and monitoring activities, including those

involving external sites.

• Act as a central resource for faculty conducting clinical

research.

• Prepare and manage required regulatory documentation, including

financial disclosure forms, delegation logs, FDA Form 1572, and

others.

• Maintain an organized regulatory binder (electronic or

physical), initiating with required documents and structured for

ongoing updates.

• Ensure prompt reporting of serious adverse events (SAEs) and

protocol deviations in accordance with applicable regulations.

• Track protocol submissions through the IRB and relevant

subcommittees, identifying bottlenecks and implementing process

improvements.

• Attend and contribute to study start-up meetings.
• Participate in routine and as-needed monitoring visits.
• Assist in preparation for and follow-up of regulatory

inspections and audits.

• Other duties as assigned.

Minimum Qualifications

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

industry-based

• 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.

Classified Title: Regulatory Specialist II

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $41,300 - $72,300 Annually ($56,800

targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon - Fri / 8:30a - 5p

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM Onc Hematologic Malignancies

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.

EEO is the Law

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https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Important legal information

http://hrnt.jhu.edu/legal.cfm