MapLight Therapeutics
Biotech
SeniorClinicalResearchAssociate(CRA)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Research Associate (CRA) at MapLight Therapeutics. Skills: Clinical monitoring, Site management, ICH GCP, Data integrity. Perform quality Investigator site monitoring. Perform compliant Investigator site monitoring”
What You'll Achieve.
Ensure subject safety; Ensure data integrity; Contribute risk management; Contribute inspection readiness; Ensure quality study oversight; Meet study milestones
Industry & Context.
Risk management; Risk mitigation
Up to 75% travel, Travel regional, Travel outside region, Periodic travel meetings
What They're Looking For.
Must Have
5 plus years clinical trial industry, 4 years clinical monitoring experience, Working knowledge GCPs, Working knowledge ALCOA+, Working knowledge pertinent regulations, Ability to build relationships, Ability to engage collaboratively, Interpersonal communication skills, Oral communication skills, Written communication skills, Ability to work independently, Ability to work proactively, Core understanding medical terminology, Core understanding clinical trial activities, High attention to detail, Focus on quality, Focus on compliance, Experience working clinical software systems, Proficiency Microsoft Office applications, Ability to travel independently
Nice to Have
CNS experience strongly preferred, Neuropsychiatry experience strongly preferred, In-patient schizophrenia experience preferred, Alzheimer’s disease psychosis experience preferred, Alzheimer's disease agitation experience preferred, Experience working smallerging biotech ideal, Experience managing multiple Investigator sites, Experience managing multiple studies simultaneously, Location near major airport preferred
What You'll Do.
Perform quality Investigator site monitoring
Perform compliant Investigator site monitoring
Perform relationship-driven Investigator site management
Ensure subject safety
Ensure data integrity
Contribute to risk management
Contribute to inspection readiness
Collaborate with internal stakeholders
Collaborate with external CRO partners
Collaborate with vendor partners
Ensure quality study oversight
Manage assigned Investigator sites
Maintain positive relationships site personnel
Prepare Pre-Study monitoring visits
Conduct Pre-Study monitoring visits
Prepare Initiation monitoring visits
Conduct Initiation monitoring visits
Prepare Interim monitoring visits
Conduct Interim monitoring visits
Prepare Closeout monitoring visits
Conduct Closeout monitoring visits
Support study team milestones
Perform centralized monitoring activities
Ensure timely resolution action items
Oversight study data quality
Oversight study data flow
Proactively identify study risks
Proactively identify study issues
Mitigate study issues
Maintain quality documentation site management
Maintain compliant documentation site management
Maintain monitoring visit reports
Maintain centralized monitoring reports
Maintain site contact reports
Reconcile Trial Master File
Reconcile Investigator Site File
Serve as MapLight point contact
Support protocol compliance
Support streamlined communications
Support timely responses site staff needs
Support training needs
Support study team inspections
Support Investigator sites inspections
Support study team audits
Support Investigator sites audits
Perform other assigned tasks
Support study team development study documents
Support study team development study procedures
Support development study monitoring plan
Support maintenance study monitoring plan
Support development study templates
Support maintenance study templates
Support development study tools
Support maintenance study tools
Support set-up study systems
Support testing study systems
Support maintenance study systems
Support related supporting documents
Support eCRF Completion Guidelines
Reconcile Trial Master File assigned sites
Reconcile Investigator Site File assigned sites
Maintain current knowledge regulatory requirements
Maintain current knowledge industry best practices
Support development process improvement monitoring function
Support development SOPs
Support revision SOPs
Support development processes
Support revision processes
Support development templates
Support revision templates
Support development tools
Support revision tools
Support development plans
Support revision plans
Contribute maintenance clinical systems
Contribute improvement clinical systems
Embody MapLight’s core values
Demonstrate MapLight’s core values
How You'll Work.
Team & Collaboration
Cross-functional internal stakeholders; External CRO partners; Vendor partners; Clinical Operations; Medical Monitoring; Data Management; Supply Chain; Clinical Compliance; Quality; Investigator sites
Communication Scope
Oral communication; Written communication
Process & Methodology
Study start up, Study close out, Study milestones
Full Job Description
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. Location: This is a remote role located in the Texas OR Arizona region. Travel: Position will require up to 75% travel with potential to be higher at times of peak activity. Every effort will be made to keep travel regional but travel outside of a region may be required on occasion. Additional periodic travel for meetings is also expected. What You’ll Do: The 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). The CRA will perform on-site monitoring and centralized monitoring to ensure subject safety, the highest data integrity, and contribute to proactive risk management and inspection readiness. 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. CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred. Responsibilities: Effectively manage assigned Investigator sites and maintain positive relationships with site personnel. Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits in accordance with MapLight SOPs and procedures, regulatory requirements and industry guidelines and best practices (ICH GCP). Support the study team in
Applying for this Senior Clinical Research Associate (CRA) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about MapLight Therapeutics?
Real rants from real employees. Read before you apply.