- 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.
Highest-signal resume keywords
- Clinical Monitoring Experience
- Good Clinical Practices (GCPs)
- EDC, eCOA, CTMS, eTMF Experience
- CNS and Neuropsychiatry Knowledge
- Interpersonal and Communication Skills
Hard Skills
- Clinical Trial Monitoring
- Regulatory Compliance
- Data Quality Management
- Documentation Management
- Medical Terminology
- Risk Management
- Study System Setup and Maintenance
- Process Improvement
- Attention to Detail
- Multi-Study Management
Soft Skills
- Collaboration
- Self-Starter
- Team Player
- Proactive Approach
- Strong Communication
Industry Keywords
- Clinical Trial Industry
- Investigator Sites
- ALCOA+
- In-Patient Trials
- Blinded Trials
- Biotech Experience
- CRO Collaboration
- Clinical Development Plan
- Site Activation
- DSMB Meetings
Tools & Technologies
- EDC
- ECOA
- CTMS
- ETMF
- EMR
- Microsoft Office Suite
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Senior Clinical Research Associate, Texas or Arizona Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
