- 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, 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.
- Embody and demonstrate MapLight's core values of Integrity, Collaboration, Bravery, and Dedication.
- 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.
- 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.
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Lead Clinical Research Associate - Burlington, United States - MapLight Therapeutics, Inc.
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.
What You'll Do:
Reporting to the Director, Monitoring Strategy and Execution, 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:
Qualifications:
Travel:
