Research Safety Reporting Specialist (DOM Infectious Disease)
Core
Manage safety reporting, adverse event reviews, and regulatory compliance for multi-centered clinical trials in solid organ transplantation and infectious diseases.
Role type
Clinical research compliance specialist (safety reporting)
Builds
Safety management plans, standard operating procedures, patient-facing forms, and research websites
Domain
Clinical research / Infectious diseases / Solid organ transplantation
Deliverable
client delivery
Required skills
Adverse event (AE) and Serious Adverse Event (SAE) review, regulatory compliance reporting, SOP development, stakeholder communication, data query resolution, safety management planning
Preferred skills
Knowledge of FDA guidelines, experience with SharePoint and WordPress
Technologies
MS SharePoint, WordPress
Responsibilities
Review and prepare Adverse Events (AEs) and Serious Adverse Events (SAEs) for medical monitor review; Submit and track resolution of AEs/SAEs to reporting agencies; Develop and maintain research websites; Generate patient-facing forms and recruitment materials; Coordinate communications with sponsors, federal agencies, and PIs; Assist with grant and annual progress report submissions
Seniority
Mid-level, hands-on IC