Lead 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 VP of Clinical Operations the Lead Clinical Research Associate will oversee an assigned MapLight study monitoring team to ensure monitoring quality and excellence in line with MapLight’s Mission, Vision, and Values. This role will maintain site management and monitoring responsibilities for assigned sites in addition to study team level work. This role will collaborate closely with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment.

Responsibilities:

• Lead and manage a team of Clinical Research Associates.
• Provide line management for CRAs inclusive of performance management and career development.
• Ensure CRAs are trained and maintain compliance with internal procedures and processes and regulatory requirements (GCP).
• Support the Clinical Operations study team with CRA resourcing.
• Maintain site management and monitoring responsibility for at least one site for the assigned study(ies).
• 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.
• Support the study team(s) in development of study-specific monitoring procedures.
• Develop and maintain the study monitoring plan, templates, and tools.
• Recommend and implement appropriate monitoring strategy based on study design, recruitment goals and the needs of the study.
• Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring.
• Act as a core member of the cross-functional study team.
• Participate in study team meetings as a subject matter expert on monitoring processes.
• Take a proactive and innovative approach to risk and issues management as related to monitoring quality or strategy.
• Recommend and implement process changes related to monitoring to support study goals and timelines.
• Support the study team in the integration of the monitoring function in study management (feasibility, site activation, site communication, risk management).