Senior Clinical Research Associate

February 5

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MapLight Therapeutics, Inc.

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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.

11 - 50 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. • What You’ll Do: Reporting to the Lead Clinical Research Associate, the CRA II/Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP). • This role will collaborate closely with key cross-functional internal stakeholders including Clinical Operations, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality study oversight from study start up through close out.

🎯 Requirements

• Approximately 4-6 years in the clinical trial industry with at least 3 years of clinical monitoring experience including complex therapeutic areas, in-patient trials, and blinded trials. • CNS and/or neuropsychiatry, 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. • Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships. • 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. • A self-starter with the ability to work independently and proactively. • Willingness to be a “team player” and take on additional responsibilities as requested. • Demonstrates 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 in all aspects of assigned work. • Experience working in various clinical software systems (EDC, CTMS, eTMF, eCOA, EMR). • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook). • Ability to travel independently by air, car and/or train. Location near a major airport preferred.