Senior Clinical Research Associate (CRA) - Texas or Arizona

• →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.

• Approximately 5 plus years in the clinical trial industry with at least 4 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. 
• Experience working in small/emerging biotech is ideal
• Experience managing multiple Investigator sites and multiple studies simultaneously.
• Willingness to travel nationally to assigned Investigator sites as needed for required visits.
• Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
• Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
• 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.
• 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 (EDC, CTMS, eTMF, eCOA, EMR).
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Ability to travel independently by air, car and/or train. Location near a major airport preferred.