About the Role
The individual will coordinate clinical trial activities, monitor site performance, and ensure accurate documentation while maintaining compliance with applicable guidelines and timelines.
Responsibilities
- Conduct site selection, initiation, and monitoring visits according to study timelines
- Verify source data accuracy and ensure completeness of case report forms
- Review regulatory documentation for compliance and proper maintenance
- Assess protocol adherence at clinical sites during monitoring activities
- Identify and report protocol deviations to the study team
- Ensure informed consent processes follow ethical and regulatory requirements
- Support query resolution between sites and data management teams
- Maintain up-to-date monitoring visit reports and follow-up actions
- Track and manage essential documents within the trial master file
- Collaborate with cross-functional teams to resolve operational issues
- Escalate critical site performance concerns to project leadership
- Participate in site training and study-specific education sessions
- Contribute to the development of monitoring plans and tools
- Assist in audit and inspection readiness efforts
- Monitor patient safety reporting processes for timeliness and accuracy
- Coordinate with central laboratories and ancillary service providers
- Support remote monitoring activities where applicable
- Ensure compliance with company standard operating procedures
- Track and report key site-level metrics and recruitment progress
- Facilitate communication between investigative sites and sponsor teams
Nice to Have
- Therapeutic experience in oncology, immunology, or rare diseases
- Certification through ACRP or SoCRA
- Experience with risk-based monitoring approaches
- Familiarity with electronic trial master file systems
- Prior work in full-service or biopharma clinical trial settings
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with remote and on-site components
Team
Collaborative clinical operations team supporting global trials
Why This Role Matters
This position plays a key role in ensuring clinical trial integrity by directly engaging with investigative sites to uphold data quality and patient safety standards.
Growth Opportunities
Performance in this role can lead to advancement into senior monitoring, project management, or specialized therapeutic area positions.
Travel Requirements
Frequent regional travel is required, including site visits and team meetings, with overnight stays as needed.
Not available for this position
