Research Safety & Compliance Specialist — Transplant Trials

The Johns Hopkins University; Baltimore (MD); On-site; USD 53,800 - 94,400; Full time

Job summary

The Johns Hopkins University is seeking a Research Safety Reporting Specialist to join the Transplant Oncology and Infectious Diseases Clinical Research Center. The role focuses on safety reporting, event review, and communications with stakeholders across multi-center trials.

Responsibilities include developing SOPs, coordinating with sponsors and PIs, reviewing AEs/SAEs, and preparing safety reports for safety monitoring boards.

Qualifications

• Bachelor’s Degree is required.
• Three years of related experience with clinical trials or medical research.

Responsibilities

• Oversee organizational document management and internal systems for event reporting.
• Develop and implement SOPs for research-related communications with external sites and stakeholders.
• Assist with grant and annual progress report submissions.
• Prepare patient-facing forms and recruitment materials in collaboration with PIs and research team.
• Develop and maintain research websites (MS SharePoint and WordPress).
• Coordinate communications with sponsors, federal agencies, and TOID CRC staff.
• Review AEs/SAEs for regulatory compliance and submit to reporting agencies.

Education

Bachelor’s Degree

Job description

The Johns Hopkins University is seeking a Research Safety Reporting Specialist to join the Transplant Oncology and Infectious Diseases Clinical Research Center. The role focuses on safety reporting, event review, and communications with stakeholders across multi-center trials.

Responsibilities include developing SOPs, coordinating with sponsors and PIs, reviewing AEs/SAEs, and preparing safety reports for safety monitoring boards.