PV Coordinator
Core
Lead project coordination and safety support for global and domestic clinical programs, focusing on adverse events, protocol inquiries, and Data and Safety Monitoring Boards.
Role type
Senior IC Principal PV Coordinator (Clinical Safety)
Builds
Operational excellence in patient safety and clinical trial management
Domain
Pharmaceutical/Biotech / Clinical Research
Deliverable
client delivery
Required skills
Protocol inquiry management, adverse event tracking, DSMB/EAC coordination, contract document preparation, meeting facilitation, data analysis, budget management, training delivery, process improvement, FDA/ICH GCP knowledge
Preferred skills
Medical terminology, delegation, presentation skills, critical thinking, independent work, stakeholder relationship building, MS Office proficiency, priority management, attention to detail
Technologies
MS Office (Word, Excel, PowerPoint, Access), external databases, tracking systems, budget management systems, client portals
Responsibilities
Coordinate review of protocol inquiries and adverse events; represent organization at DSMB/EAC meetings; prepare and review contractual documents; facilitate project meetings and manage minutes; manage project budgets and expensing; develop training materials and SOPs; mentor junior staff; perform data entry and system reconciliations; conduct quality reviews and process improvements.
Seniority
Senior, hands-on IC with mentorship responsibilities