Lead Clinical Research Associate

Responsibilities

• Lead and manage a team of Clinical Research Associates, providing line management and career development
• Maintain site management and monitoring responsibilities for assigned sites
• Conduct Pre-Study, Initiation, Interim, and Closeout monitoring visits in accordance with ICH GCP
• Develop and maintain study monitoring plans, templates, and tools
• Perform centralized monitoring activities to ensure data quality and mitigate study risks
• Provide oversight of study monitoring through report reviews and co-monitoring visits
• Support the development and revision of SOPs and clinical systems

Requirements

• Bachelor’s degree in a relevant field or RN
• 7+ years in the clinical trial industry with at least 5 years of clinical monitoring
• Experience with complex therapeutic areas, in-patient trials, and blinded trials
• Experience managing a clinical monitoring team at a pharmaceutical/biotech company or CRO
• Strong working knowledge of GCP, ALCOA+, and pertinent regulations
• Proficiency with CTMS, eTMF, and RIM software systems
• Ability to travel up to 30-40%

Preferred Qualifications

• Recent CNS or neuropsychiatry experience (specifically in-patient schizophrenia and Alzheimer’s disease psychosis)
• Experience working in small or emerging biotech environments

About the Company

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders using cutting-edge technologies like optogenetics and spatial transcriptomics.