Note: The job is a remote job and is open to candidates in USA. Investigo is supporting a growing clinical research organization seeking a Clinical Trials Assistant to join its Clinical Operations team. The role supports clinical trials 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 clinical 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 clinical research sites as needed
- Tracking monitoring visit reports and study progress
- Supporting enrollment tracking and weekly study updates
- Assisting with clinical 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 clinical tracking systems
- Identifying and escalating study issues appropriately
Skills
- 2+ years of clinical research experience
- General understanding of GCP and ICH guidelines
- Strong organizational and coordination skills
- Excellent attention to detail
- Strong written and verbal communication
- Comfortable managing multiple priorities
- Strong Microsoft Office skills
- Ability to work effectively with cross-functional clinical teams
- Equivalent clinical research experience
- Experience supporting CNS, psychiatry, neurology, pain, addiction, sleep, metabolic, obesity, diabetes, or other clinical research
- A BS/BA is preferred
- CTA experience
Benefits
- Fully remote work arrangement
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