Lead CRA

Who We Are

MapLight Therapeutics is a clinical stage biotech company focusing on drug discovery for central nervous system disorders. We leverage cutting-edge technologies such as optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies for psychiatric symptoms.

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 in the 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, etc.)
• Support the study team and Investigator sites during inspections or audits, as needed.
• Accomplish other tasks as assigned.
• Provide oversight of study monitoring
• Review monitoring visit reports to ensure MapLight quality standards are met.
• Review Key Performance Indicators for assigned CRAs to ensure high performance and compliance with requirements.
• Perform oversight visits and co-monitoring visits to ensure quality 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.
• Maintain a forward-thinking approach to monitoring process to support department and corporate growth and change.
• Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.

Qualifications

• Bachelor’s degree in a relevant field or RN; approximately 7+ years in the clinical trial industry with at least 5 years of clinical monitoring including complex therapeutic areas, in-patient trials, and blinded trials. (Recent CNS and/or neuropsychiatry, specifically in-patient schizophrenia and Alzheimer’s disease psychosis experience, strongly preferred.)
• Experience working in small/emerging biotech a plus
• Experience managing a clinical monitoring team at a pharmaceutical or biotech company or CRO.
• Demonstrated ability serve as a role model and mentor to more junior clinical staff.
• Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
• Ability to engage collaboratively with internal and external stakeholders in a professional manner.
• Strong interpersonal, oral, and written communication skills.
• A self-starter with the ability to work independently and proactively.
• Willingness to be a “team player” and take on additional responsibilities as requested.
• Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• High attention to detail and focus on quality and compliance in all aspects of assigned work.
• Experience working in various clinical software systems (CTMS, eTMF, RIM).
• Proficiency with Word, Excel, PowerPoint, and Microsoft Office.
• Ability to travel independently by air, car and/or train. Location near a major airport preferred.

Benefits

Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

Pay

$165,000 - $185,000 USD

Schedule

Position will require up to 30-40% travel with potential to be higher at times of peak study activity. Additional periodic travel for meetings is expected.