Senior Clinical Research Associate, Early Clinical Development

Jobtailor; Carlsbad (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Jobtailor is seeking an on-site Clinical Research Monitor in California to lead site visits, train staff, and ensure adherence to GCP and ICH guidelines. You will manage regulatory submissions, data quality, and budget tracking while supporting cross-functional teams to drive study execution.

The ideal candidate has 1.5+ years of on-site monitoring experience, strong knowledge of regulatory requirements, and willingness to travel as required by projects.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience)
• Requires at least 1.5 years of on-site monitoring experience
• Strong understanding of GCP, ICH guidelines, and regulatory requirements

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits
• Collaborate with site staff on subject recruitment strategies
• Deliver protocol and study-specific training to site personnel
• Assess site performance and protocol adherence, escalating quality concerns
• Track regulatory submissions, subject enrollment, CRF completion, and data-query resolution
• Collect and maintain essential documents in the TMF and ISF
• Document site management activities, visit outcomes, and follow-up actions
• Collaborate with cross-functional project teams to support study execution
• Support site-level recruitment planning and financial management, including invoice collection and budget tracking

Skills

On-Site Monitoring

GCP Understanding

ICH Guidelines

Regulatory Familiarity

Site Documentation

Education

Bachelor’s degree in life sciences or health-related field

Tools

TMF

ISF

Job description

• Conduct site selection, initiation, monitoring, and close-out visits
• Collaborate with site staff on subject recruitment strategies
• Deliver protocol and study-specific training to site personnel
• Assess site performance and protocol adherence, escalating quality concerns
• Track regulatory submissions, subject enrollment, CRF completion, and data-query resolution
• Collect and maintain essential documents in the TMF and ISF
• Document site management activities, visit outcomes, and follow-up actions
• Collaborate with cross-functional project teams to support study execution
• Support site-level recruitment planning and financial management, including invoice collection and budget tracking

Requirements

• Bachelor’s degree in life sciences or health-related field (or equivalent experience)
• Requires at least 1.5 years of on-site monitoring experience
• Strong understanding of GCP, ICH guidelines, and regulatory requirements
• Ability to travel as required by the project

Core Competencies

Demonstrates expertise in site management, including site selection, monitoring, and adherence to regulatory requirements. Proficient in collaborating with cross-functional teams to ensure effective study execution and compliance with GCP and ICH guidelines.

Highest-signal resume keywords

• On-Site Monitoring Experience
• GCP Understanding
• ICH Guidelines Knowledge
• Regulatory Requirements Familiarity
• Site Management Activities Documentation

Hard Skills

• Site Selection
• Protocol Training
• Data-Query Resolution
• CRF Completion
• Regulatory Submissions Tracking
• Budget Tracking
• Subject Recruitment Strategies
• Quality Concern Escalation
• Essential Document Maintenance
• Visit Outcome Documentation

Soft Skills

• Collaboration
• Communication
• Problem-Solving

Industry Keywords

• Life Sciences
• Health-Related Field
• Clinical Research

Tools & Technologies

• TMF
• ISF