CRA I, no monitoring experience required

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
• Evaluate site and site staff performance and provide recommendations and action plans
• Maintain knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs/processes
• Verify informed consent, confidentiality, subject safety, clinical data integrity, and protocol compliance
• Assess site processes and conduct source document review of site source documents and medical records
• Verify clinical data entered in case report forms is accurate and complete
• Apply query resolution techniques and drive query resolution to closure within agreed timelines
• Use hardware and software for clinical project data review and capture
• Verify compliance with electronic data capture requirements
• Perform investigational product inventory, reconciliation, storage, dispensing, administration, labelling, import, and return reviews as applicable
• Review Investigator Site Files and reconcile them with the Trial Master File
• Ensure essential documents are archived according to local guidelines and regulations
• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Track observations, ongoing status, and action items through tracking systems
• Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
• Act as liaison with project site personnel, independently or with another CRA or Central Monitoring Associate
• Ensure assigned sites and project-specific site team members are trained and compliant
• Prepare for and attend Investigator Meetings, sponsor meetings, global monitoring meetings, and clinical training
• Support audit readiness, audit preparation, and follow-up actions
• For Real World Late Phase, support the study lifecycle from site identification through close-out, chart abstraction, data collection, and collaboration with sponsor affiliates, medical science liaisons, and local country staff

Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• For Real World Late Phase: knowledge of local requirements for real world late phase study designs
• For Real World Late Phase: chart abstraction and data collection capabilities
• Ability to adapt to changing priorities under the oversight of the Lead CRA
• Ability to ensure assigned sites and project-specific site team members are trained and compliant with applicable requirements

Core Competencies

Demonstrates expertise in site management, compliance with ICH/GCP guidelines, and effective communication with site personnel. Proficient in clinical data integrity, query resolution, and supporting audit readiness throughout the study lifecycle.

Highest-signal resume keywords

• Site Management
• ICH/GCP Guidelines Knowledge
• Clinical Data Integrity
• Query Resolution Techniques
• Chart Abstraction

ATS Optimization Keywords

Hard Skills

• Site Qualification
• Site Initiation
• Interim Monitoring
• Source Document Review
• Data Collection
• Protocol Compliance
• Investigational Product Management
• Electronic Data Capture Compliance
• Clinical Project Data Review
• Action Plan Development

Soft Skills

• Excellent Communication
• Presentation Skills
• Interpersonal Skills
• Adaptability
• Team Collaboration

Certifications & Qualifications

• Bachelor’s Degree
• RN in a Related Field

Industry Keywords

• Good Clinical Practice
• Regulatory Requirements
• Real World Late Phase Studies
• Site Staff Training
• Audit Readiness

Tools & Technologies

• Tracking Systems
• Clinical Trial Management Software
• Data Review Software
• Electronic Data Capture Systems