Senior Clinical Research Associate - Florida

Job not on LinkedIn

🔥 13 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

• Perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management according to MapLight SOPs, ICH GCP, and regulatory best practices • Perform on-site and centralized monitoring to ensure subject safety, data integrity, proactive risk management, and inspection readiness • Collaborate with Clinical Operations, Medical Monitoring, Data Management, Supply Chain, Clinical Compliance and Quality, CROs, and vendors • Manage assigned Investigator sites and maintain positive site relationships • 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, resolve action items, oversee study data quality and flow, and manage risks and issues • Maintain compliant monitoring documentation, reports, Trial Master Files, and Investigator Site Files • Serve as MapLight’s primary contact for Investigator sites regarding protocol compliance, communication, responses, and training • Support inspections and audits • Support development of study documents, procedures, monitoring plans, templates, tools, and clinical systems • Support setup, testing, and maintenance of EDC, eCOA, IRT, and related study documents • Review and reconcile Trial Master Files and Investigator Site Files for inspection readiness • Maintain knowledge of monitoring regulations and risk-based monitoring best practices • Support monitoring-function process improvement and SOP development • Contribute to clinical systems improvement and efficiency

🎯 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 ideal • Experience managing multiple Investigator sites and multiple studies simultaneously • Willingness to travel nationally to assigned Investigator sites as needed • Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations • Ability to engage collaboratively with internal and external stakeholders • Strong interpersonal, oral, and written communication skills • Ability to work independently and proactively • Willingness to take on additional responsibilities as requested • 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

🏖️ 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