Senior Clinical Research Associate, Texas or Arizona

Job not on LinkedIn

🔥 12 hours ago

🌵 Arizona, Texas – Remote

🌵 Arizona – Remote 🤠 Texas – Remote

💵 $145k - $160k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Manage assigned Investigator sites and maintain positive relationships with site personnel • Prepare for and conduct Pre-Study, Initiation, Interim, and Closeout monitoring visits • Support study milestones including site activation, DSMB meetings, and database lock • Perform centralized monitoring between on-site visits to resolve action items, oversee study data quality and flow, and manage study risks • Maintain quality and ALCOA+ compliant documentation, including monitoring visit reports, centralized monitoring reports, site contact reports, and Trial Master File/Investigator Site File records • Serve as the main MapLight point of contact for Investigator sites • Support protocol compliance, communications, site staff needs, and training needs • Support inspections and audits • Support development of study documents and procedures • Support monitoring plans, templates, and tools • Support setup, testing, and maintenance of study systems including EDC, eCOA, and IRT • Reconcile Trial Master File and Investigator Site File records for inspection readiness • Maintain knowledge of regulatory requirements and monitoring best practices • Support monitoring-function and process improvement • Support SOP, process, template, tool, and plan development and revision • Contribute to clinical systems maintenance and efficiency improvements • Collaborate with Clinical Operations, Medical Monitoring, Data Management, Supply Chain, Clinical Compliance and Quality, CROs, and vendors

🎯 Requirements

• Approximately 5 plus years in the clinical trial industry with at least 4 years of clinical monitoring experience, including complex therapeutic areas, in-patient trials, and blinded trials • CNS and/or neuropsychiatry experience, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred • Experience working in small/emerging biotech is ideal • Experience managing multiple Investigator sites and multiple studies simultaneously • Willingness to travel nationally to assigned Investigator sites as needed for required visits • Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations • Ability to engage collaboratively with internal and external stakeholders in a professional manner • Strong interpersonal, oral, and written communication skills • Self-starter able to work independently and proactively • Willingness to be a team player and take on additional responsibilities as requested • Core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan • High attention to detail and focus on quality and compliance • Experience with clinical software systems including EDC, CTMS, eTMF, eCOA, and EMR • Proficiency with Microsoft Office applications: Word, Excel, PowerPoint, and Outlook • Ability to travel independently by air, car, and/or train; location near a major airport preferred • Ability to work remotely from the Texas or Arizona region

🏖️ Benefits

• Annual bonus opportunity • Medical insurance • Dental insurance • Vision insurance • Life insurance • AD&D insurance • Short-term disability • Long-term disability • 401(K) plan with match • Stock options • Flexible non-accrual paid time off • Parental leave