Senior Clinical Trial Associate – Sr. CTA
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Job Description
Senior Clinical Trial Associate supporting clinical operations and trial documentation at MapLight Therapeutics, a CNS-focused clinical-stage biotech. Coordinating study teams, vendors, TMF compliance, meetings, and clinical trial trackers.
Responsibilities:
- Support Clinical Operations and project teams across all phases of clinical projects
- Interact with Clinical teams, site staff, and vendors in the U.S. and worldwide to support project-specific tasks and overall clinical trial management
- Maintain and manage study-system user access and deactivation requests
- Coordinate materials for internal and external meetings
- Distribute safety alerts and relevant documents as required
- Maintain study-team and vendor contact information
- Assist with planning, organizing, and executing study-specific meetings; write and distribute agendas, minutes, and updates
- Review, format, and finalize study-related templates, plans, and manuals as needed
- Assist with maintaining clinical trial insurance
- Route Clinical Research Organization/study-team questions and requests for resolution
- Participate in clinical data review as required
- Maintain complete Trial Master File documentation and conduct ongoing quality and SOP/ICH-GCP compliance reviews
- Route, track, and file Clinical documents
- Review site Clinical regulatory documentation for completeness and dates as needed
- Develop and maintain study-related trackers and analyze or update tracker data
- Support Study Team Leads and Operational Team Leads with other assigned duties
Requirements:
- Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered.
- Minimum 2+ years in the biotech /pharmaceutical industry /clinical trial management area
- Competency of the drug development process with knowledge of ICH-GCP is a plus
- Strong interpersonal, organizational and planning skills
- Excellent verbal and written communication skills
- Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly
- Ability to identify areas for efficiency across studies
- Ability to travel up to 35%
Benefits:
- Annual bonus opportunity
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Accidental death and dismemberment (AD&D) insurance
- Short-term disability insurance
- Long-term disability insurance
- 401(k) plan with match
- Stock options
- Flexible non-accrual paid time off
- Parental leave
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