Senior Clinical Research Associate, Texas or Arizona

Stellenbeschreibung:

Manage assigned Investigator sites and maintain positive relationships with site personnel
Prepare for and conduct Pre-Study, Initiation, Interim, and Closeout monitoring visits
Support study milestones including site activation, DSMB meetings, and database lock
Perform centralized monitoring between on-site visits to resolve action items, oversee study data quality and flow, and manage study risks
Maintain quality and ALCOA+ compliant documentation, including monitoring visit reports, centralized monitoring reports, site contact reports, and Trial Master File/Investigator Site File records
Serve as the main MapLight point of contact for Investigator sites
Support protocol compliance, communications, site staff needs, and training needs
Support inspections and audits
Support development of study documents and procedures
Support monitoring plans, templates, and tools
Support setup, testing, and maintenance of study systems including EDC, eCOA, and IRT
Reconcile Trial Master File and Investigator Site File records for inspection readiness
Maintain knowledge of regulatory requirements and monitoring best practices
Support monitoring-function and process improvement
Support SOP, process, template, tool, and plan development and revision
Contribute to clinical systems maintenance and efficiency improvements
Collaborate with Clinical Operations, Medical Monitoring, Data Management, Supply Chain, Clinical Compliance and Quality, CROs, and vendors

Requirements

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 experience, 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
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
Self-starter able to work independently and proactively
Willingness to be a team player and take on additional responsibilities as requested
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
Experience with clinical software systems including EDC, CTMS, eTMF, eCOA, and EMR
Proficiency with Microsoft Office applications: Word, Excel, PowerPoint, and Outlook
Ability to travel independently by air, car, and/or train; location near a major airport preferred
Ability to work remotely from the Texas or Arizona region

Core Competencies

Demonstrates expertise in clinical trial monitoring, including managing Investigator sites, ensuring compliance with Good Clinical Practices (GCPs), and maintaining high-quality documentation. Proficient in utilizing clinical software systems and collaborating effectively with diverse stakeholders to support study milestones and process improvements.