Senior Clinical Research Associate, Texas or Arizona

Jobtailor; Deutschland; Remote; EUR 78.000 - 103.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Clinical Monitoring Specialist to oversee Investigator sites, ensure GCP compliance, and maintain ALCOA+ documentation throughout all monitoring visits and inspections.

You will coordinate Pre-Study to Closeout visits, support trial milestones, travel nationally to sites, and collaborate with Clinical Operations, Data Management, and CRO partners to drive data quality and process improvements.

Qualifikationen

• Approximately 5+ years in clinical trial monitoring with complex trials.
• Experience with CNS/neuropsychiatry, inpatient schizophrenia or Alzheimer’s disease studies preferred.
• Experience managing multiple Investigator sites and multiple studies simultaneously.
• Willingness to travel nationally for required site visits.
• Strong knowledge of Good Clinical Practices (GCPs) and ALCOA+ documentation standards.

Aufgaben

• 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 to resolve action items and ensure data quality.
• Maintain ALCOA+ compliant documentation and Trial Master File records.
• Collaborate with Clinical Operations, Medical Monitoring, Data Management, and CROs.

Kenntnisse

Clinical Trial Monitoring

GCPs

Data Quality Management

Documentation Management

Medical Terminology

Risk Management

Process Improvement

Attention to Detail

Multi-Study Management

Tools

EDC

eCOA

CTMS

eTMF

EMR

Microsoft Office Suite

Jobbeschreibung

• 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