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Salary: USD 145,000 - 160,000 / annual
MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders, combining optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop therapies for psychiatric symptoms.
The Senior Clinical Research Associate (CRA) will lead quality and compliant investigator site monitoring and relationship-driven site management aligned with MapLight's standard operating procedures, mission, and industry best practices (ICH GCP). You will perform on-site and centralized monitoring to ensure subject safety, data integrity, and proactive risk management while maintaining inspection readiness.
Key responsibilities include:
- Effectively manage assigned investigator sites and maintain positive relationships with site personnel
- Prepare for and conduct pre-study, initiation, interim, and closeout monitoring visits per SOPs, regulatory requirements, and ICH GCP guidelines
- Support study team in meeting milestones (site activation, DSMB meetings, database lock)
- Perform centralized monitoring between on-site visits to resolve action items, oversee data quality, and proactively identify and mitigate study risks
- Maintain quality and compliant documentation including monitoring visit reports, centralized monitoring reports, and trial master files
- Serve as primary MapLight point of contact for investigator sites regarding protocol compliance, communications, and training
- Support study teams and sites during inspections or audits
- Collaborate with cross-functional internal teams (Clinical Operations, Medical Monitoring, Data Management, Supply Chain, Clinical Compliance) and external CRO/vendor partners
- Support development and maintenance of study monitoring plans, templates, and tools
- Assist with setup, testing, and maintenance of study systems (EDC, eCOA, IRT)
- Contribute to SOP development, process improvement, and clinical systems enhancement
The role requires up to 75% travel with potential for higher travel during peak activity periods. Travel will be primarily regional but may extend nationally as needed.
Qualifications:
- Approximately 5+ years in clinical trial industry with at least 4 years of clinical monitoring experience in complex therapeutic areas, in-patient trials, and blinded trials
- CNS and/or neuropsychiatry experience strongly preferred, specifically in-patient schizophrenia and/or Alzheimer's disease psychosis or agitation
- Experience in small/emerging biotech ideal
- Proven ability to manage multiple investigator sites and studies simultaneously
- Willingness to travel nationally to assigned sites
- Strong relationship-building skills and ability to foster collaboration and trust
- Strong working knowledge of Good Clinical Practices (GCP), ALCOA+, and pertinent regulations
- Excellent interpersonal, oral, and written communication skills
- Self-starter capable of working independently and proactively
- Demonstrated understanding of medical terminology and clinical trial activities
- High attention to detail with focus on quality and compliance
- Experience with 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 major airport preferred
