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Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately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.
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 firstname.lastname@example.org. 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.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.
BACK TO TOP
FDLI Career Center is Just One of the Benefits.
Discover what else FDLI Membership has to offer!
The job you are trying to reach from was originally posted at FDLI Career Center.