Senior Clinical Research Associate (CRA)

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.

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). 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 meeting study milestones (site activation, DSMB meetings, database lock, etc.).
• Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues.
• Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
• Serve as the main MapLight point of contact for Investigator sites to support protocol compliance, streamlined communications, timely responses to site staff needs, and training needs.
• Support the study team and Investigator sites during inspections or audits, as needed.
• Perform other assigned tasks, as requested.
• Support the study team(s) in development of study documents and procedures.

As Requested

• Support the development and maintenance of the study monitoring plan, templates, and tools.
• Support the set-up, testing, and maintenance of study systems (EDC, eCOA, IRT, etc.) as well as related supporting documents (manuals, eCRF Completion Guidelines, etc.) in collaboration with MapLight and CRO/vendor study team members.
• Continually review and reconcile the Trial Master File and Investigator Site File for assigned sites to ensure inspection readiness.
• Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring.
• Support development and process improvement for the MapLight monitoring function.
• Support development and revision of SOPs, processes, templates, tools, and plans with the aim of continual improvement and streamlining.
• Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.
• Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.

Qualifications

• 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.