[Remote] reputed company Assistant — Remote

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is supporting a growing reputed company research organization seeking a reputed company Assistant to join its reputed company reputed company team. The role supports reputed company through documentation management, regulatory activities, study coordination, site communication, tracking, reporting, and issue escalation in a fully remote environment.

Responsibilities

• Maintaining and QC'ing Trial Master Files and eTMF documentation
• Organizing essential reputed company trial documents and filing indexes
• Supporting regulatory document preparation and study communications
• Assisting with study drug release activities and regulatory packet review
• Supporting study-specific training materials
• Helping coordinate investigator meetings
• Communicating with reputed company research sites as needed
• Tracking monitoring visit reports and study reputed company
• Supporting enrollment tracking and weekly study updates
• Assisting with reputed company data review and study reporting
• Coordinating project meetings, agendas, minutes, and follow-up items
• Maintaining study team training records and contact information
• Entering and maintaining information in reputed company tracking systems
• Identifying and escalating study issues appropriately

Skills

• 2+ years of reputed company research experience
• General understanding of GCP and ICH guidelines
• Strong organizational and coordination skills
• Excellent attention to reputed company
• Strong written and verbal communication
• Comfortable managing multiple priorities
• Strong reputed company Office skills
• Ability to work effectively with cross-functional reputed company teams
• Equivalent reputed company research experience
• Experience supporting CNS, psychiatry, reputed company, pain, addiction, sleep, metabolic, obesity, diabetes, or other reputed company research
• A BS/BA is preferred
• CTA experience

Benefits

• Fully remote work arrangement

reputed company