What You'll Do
Oversee clinical trial sites from initiation through close-out, conducting remote and on-site visits to assess compliance with ICH-GCP, regulatory standards, and study protocols. Evaluate site performance, identify risks, and implement corrective actions when necessary. Review source documents and case report forms to verify data accuracy and completeness, resolving queries within established timelines.
Ensure informed consent procedures are properly documented and maintained, and confirm that investigational product handling meets protocol requirements, including storage, dispensing, and accountability. Support audit readiness by maintaining accurate Investigator Site Files and aligning them with Trial Master File content. Communicate regularly with site staff and project teams to address issues and support recruitment and retention efforts.
Use electronic data capture systems and monitoring tools to track study progress and maintain compliance. Participate in sponsor meetings, training sessions, and team discussions to stay aligned with project goals. For late-phase real-world studies, perform chart abstraction and collaborate with local stakeholders to support data collection and site engagement.
Requirements
- Bachelor’s degree or RN in a related field, or equivalent combination of education and experience
- Familiarity with ICH-GCP guidelines, regulatory requirements, and clinical trial protocols
- Proficiency with electronic data capture systems and clinical monitoring software
- Strong organizational, communication, and problem-solving skills
- Willingness and ability to travel up to 75% of the time
- Ability to adapt to changing priorities and manage multiple responsibilities independently
Benefits
- Flexible paid time off and sick leave in compliance with local regulations
- Medical, dental, and vision health coverage
- 401(k) plan with company match
- Employee Stock Purchase Plan eligibility
- Performance-based bonus and commission opportunities
- Car allowance or company vehicle
