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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 perform quality and compliant investigator site monitoring and relationship-driven site management aligned with MapLight's SOPs, mission, vision, values, and industry best practices (ICH GCP). The role encompasses on-site and centralized monitoring to ensure subject safety, data integrity, proactive risk management, and 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 ensure timely resolution of action items, data quality oversight, and proactive risk/issue management
- Maintain quality and compliant documentation (monitoring visit reports, centralized monitoring reports, site contact reports, TMF/ISF)
- Serve as primary MapLight point of contact for investigator sites regarding protocol compliance, communications, and training
- Support study team and sites during inspections or audits
- Support development and maintenance of monitoring plans, templates, and tools
- Support setup, testing, and maintenance of study systems (EDC, eCOA, IRT) and related documentation
- Maintain current knowledge of regulatory requirements and industry best practices
- Contribute to process improvement and SOP development
- Embody MapLight's core values: Integrity, Collaboration, Bravery, and Dedication
This is a remote role based in Texas or Arizona with up to 75% travel required (potentially higher during peak activity). Travel will be primarily regional but may extend nationally. Additional periodic travel for meetings is expected.
Qualifications:
- Approximately 5+ years in 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 strongly preferred, specifically in-patient schizophrenia and/or Alzheimer's disease psychosis or Alzheimer's disease agitation
- Experience working in small/emerging biotech ideal
- Experience managing multiple investigator sites and multiple studies simultaneously
- Willingness to travel nationally to assigned investigator sites; location near major airport preferred
- Ability to build strong collaborative relationships with investigator sites
- Strong working knowledge of Good Clinical Practices (GCP), ALCOA+, and pertinent regulations
- Ability to engage collaboratively with internal and external stakeholders
- Strong interpersonal, oral, and written communication skills
- Self-starter with ability to work independently and proactively
- Demonstrates core understanding of medical terminology and clinical trial activities
- High attention to detail and 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
