About the Role
The position involves coordinating clinical trial activities, ensuring data integrity, and supporting site management to advance targeted therapeutic research.
Responsibilities
- Conduct site selection and qualification visits to assess capability and compliance
- Perform routine monitoring visits, both on-site and remotely, to ensure study adherence
- Verify accuracy and completeness of case report forms and source documentation
- Assist in the development of study-related materials and monitoring plans
- Ensure informed consent processes meet regulatory and ethical standards
- Track and resolve data queries in coordination with data management teams
- Maintain up-to-date regulatory binders for each assigned site
- Report site progress and issues to project managers and sponsors
- Support site initiation and closeout activities as needed
- Monitor protocol compliance and escalate deviations when identified
- Coordinate communication between investigative sites and central study teams
- Assist in preparing monitoring visit reports and follow-up actions
- Ensure adverse events are documented and reported per study requirements
- Participate in investigator meetings and training sessions
- Track essential documents for regulatory compliance
- Collaborate with cross-functional teams to meet study milestones
- Support audit and inspection readiness at clinical sites
- Review site performance metrics and recommend improvements
- Ensure proper handling and accountability of investigational products
- Maintain monitoring documentation in accordance with SOPs
- Stay current with GCP, FDA, and ICH guidelines
- Escalate site risks and non-compliance issues promptly
- Contribute to process improvement initiatives within clinical operations
- Assist in the onboarding of new sites to the study
- Support centralized and on-site monitoring strategies
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model available
Team
Part of a specialized clinical operations team supporting precision medicine trials
Therapeutic Focus
Work emphasizes trials in oncology, immunology, and other precision-based therapeutic areas leveraging biomarker strategies
Professional Development
Opportunities for advancement based on performance, experience, and leadership potential within clinical operations
May offer visa sponsorship depending on role level and qualifications
