Oncology Clinical Research Regulatory Specialist

Johns Hopkins University; Washington (District of Columbia); Hybrid; USD 48,000 - 84,000; Full time

Job summary

Johns Hopkins University is seeking a Clinical Research Regulatory Specialist to oversee regulatory maintenance of clinical trials within the Oncology Clinical Research Program. The role supports investigator-initiated studies, sponsor relationships, and compliance trainings for program staff.

Under supervision, you will handle IRB amendments, regulatory documents, and quality control while training staff and assisting with budgets and overall study coordination.

Qualifications

• Bachelor's degree required.
• Five years of related experience in clinical research in an academic setting.
• Minimum of 2 years' experience in clinical trial and/or clinical research in a patient setting.

Responsibilities

• Evaluate study status and complete regulatory requirements, including protocol submissions to IRB for timely amendments.
• Revise investigator-initiated studies with consistent language and proper SAE reporting requirements.
• Submit all study amendments to the IRB, Cancer Center Cores, and other regulatory documents.
• Track protocols through Oncology and IRB approvals to reduce delays.
• Support data quality and timely submission and adherence to guidelines for National Cancer Institute trials.
• Conduct internal QA measures and training to ensure regulatory compliance.
• Maintain proficiency with Epic, OnCore, eReg, and eIRB systems for data accuracy.
• Assist with program operations and staff orientation, creating SOPs and checklists.
• Participate in cancer center initiatives and quality improvement groups.
• Maintain knowledge of Good Clinical Practice and SKCCC policies.

Education

Bachelor's Degree in a related field

Job description

Johns Hopkins University is seeking a Clinical Research Regulatory Specialist to oversee regulatory maintenance of clinical trials within the Oncology Clinical Research Program. The role supports investigator-initiated studies, sponsor relationships, and compliance trainings for program staff.

Under supervision, you will handle IRB amendments, regulatory documents, and quality control while training staff and assisting with budgets and overall study coordination.