The Department of Oncology, Division of Cancer Immunology/GI Clinical Research is looking to fill the position of Regulatory Specialist II. The Clinical Research Regulatory Specialist II will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Working closely with the Sponsor-Investigator and IND Specialist, this position will assist in the submission of investigator initiated trials to the appropriate regulatory agencies for review, such as the Food and Drug Administration (FDA) and Recombinant DNA Advisory Committee (RAC). In addition, this position will assist in the ongoing maintenance of Sponsor-Investigator held INDs. This includes, but is not limited to protocol amendments, Investigator Brochure amendments, annual reports, IND safety reports, Chemistry, Manufacturing, and Controls (CMC) updates, and oversight of investigational drug supply.
DUTIES AND RESPONSIBILITIES
Provide assistance in the submission of Investigational New Drug Applications (IND)
Provide regulatory guidance to IND sponsors, clinical investigators, and clinical staff for investigator initiated clinical trials
Provide assistance with IND management and submissions
Coordinate and review documentation for amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs
Compile and maintain IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately
Review clinical trial databases to assess clinical data quality and accuracy
Monitor investigational drug supply
Bachelor's degree in health sciences, biological sciences, or related field and three years clinical trial regulatory experience at an academic, government, or pharmaceutical industry environment required. Additional education may substitute for required experience to the extent permitted by the JHU equivalency formula. Master's degree in regulatory, health sciences, biological sciences, or related field preferred.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Salary Range: $37,781 - $51,950
Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5hrs.
Location: East Baltimore
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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.
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