About the Role
The position involves monitoring clinical trial sites to ensure compliance with protocols, regulations, and standard operating procedures while supporting the advancement of clinical development programs.
Responsibilities
- Conduct initial and ongoing monitoring visits to clinical trial sites
- Verify accurate and timely completion of case report forms
- Ensure informed consent forms are properly documented and stored
- Review source documents for consistency with trial data entries
- Assess site compliance with study protocols and regulatory requirements
- Identify and report protocol deviations to the study team
- Assist in the preparation of monitoring visit reports
- Support site initiation and closeout activities
- Coordinate communication between sites and central project teams
- Track and resolve data queries in collaboration with data management
- Participate in investigator meetings and training sessions
- Maintain up-to-date monitoring documentation and regulatory binders
- Ensure proper handling and accountability of investigational products
- Collaborate with cross-functional teams to address site-level challenges
- Escalate critical issues to senior project staff promptly
- Support audit readiness at clinical sites
- Contribute to the development of monitoring plans
- Verify essential document collection per regulatory guidelines
- Monitor patient safety reporting processes
- Assist in central laboratory coordination
- Track enrollment progress across assigned sites
- Support risk-based monitoring strategies
- Ensure adherence to Good Clinical Practice standards
- Participate in internal study team meetings
- Contribute to process improvement initiatives
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility based on project and team needs
Team
Part of a specialized clinical operations team supporting complex therapeutic area studies
About Us
This organization specializes in delivering precision medicine solutions through advanced diagnostics and clinical development services. Its focus spans biomarker-driven trials and personalized therapeutics across complex disease areas.
Why Join Us?
Professionals here engage in high-impact clinical research with opportunities for growth, mentorship, and involvement in innovative trial designs. The culture emphasizes scientific rigor, collaboration, and operational excellence.
Not available for this position
