Senior Clinical Trial Associate – Sr. CTA

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $115k - $130k / year

⏰ Full Time

🟠 Senior

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MapLight Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

MapLight Therapeutics, Inc. is a biotechnology company dedicated to transforming the treatment of brain disorders, including conditions such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. They leverage advanced technologies like optogenetics and transcriptomics to identify specific neural circuits involved in these disorders, aiming to develop targeted therapeutics with the potential to significantly improve patient outcomes. Their innovative discovery platform supports a robust pipeline of clinical and preclinical trials focused on addressing significant unmet medical needs in central nervous system conditions.

📋 Description

• 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