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.

In addition to the duties described above

• Coordinate day-to-day clinical trial activities to ensure protocol adherence and efficient study execution.
• Support participant screening, enrollment, and scheduling of study visits in collaboration with study teams.
• Maintain accurate source documentation and ensure timely, high-quality data entry into study databases.
• Assist with safety reporting, including adverse event and protocol deviation documentation, in accordance with regulatory requirements.
• Facilitate communication among investigators, study staff, sponsors, CROs, and institutional partners to support ongoing trial operations.
• Prepare for and support sponsor monitoring visits, audits, and study close-out activities.

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

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: M-F, 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Hybird/ School of Medicine Campus
Department name: SOM DOM Cardiology
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
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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.

In addition to the duties described above

• Coordinate day-to-day clinical trial activities to ensure protocol adherence and efficient study execution.
• Support participant screening, enrollment, and scheduling of study visits in collaboration with study teams.
• Maintain accurate source documentation and ensure timely, high-quality data entry into study databases.
• Assist with safety reporting, including adverse event and protocol deviation documentation, in accordance with regulatory requirements.
• Facilitate communication among investigators, study staff, sponsors, CROs, and institutional partners to support ongoing trial operations.
• Prepare for and support sponsor monitoring visits, audits, and study close-out activities.

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

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: M-F, 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Hybird/ School of Medicine Campus
Department name: SOM DOM Cardiology
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
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm