Job Opportunity: Clinical Research Regulatory Specialist II, Johns Hopkins University, Baltimore, Maryland
Regulatory Specialist II
The Department of Oncology is seeking a Clinical Research Regulatory Specialist II that 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Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately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
Qualifications:
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. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Preferred:
Advanced degree in regulatory, health sciences, biological sciences, or related field desired.
For more information contact: Jennifer Durham at juram1@jhmi.edu