What You'll Do
Oversee key aspects of clinical trial execution by managing investigative sites from qualification through close-out. Conduct on-site and remote monitoring visits to ensure adherence to protocols, regulatory standards, and ICH-GCP or Good Pharmacoepidemiology Practice (GPP) guidelines. Evaluate site performance, identify risks, and escalate critical issues with actionable recommendations.
Review source documents and medical records to verify data accuracy in case report forms, applying query resolution methods to maintain data integrity. Support electronic data capture compliance and assist with investigational product accountability, including storage, dispensing, and blinding integrity. Maintain and reconcile the Investigator Site File against the Trial Master File, ensuring essential documents are complete and archived appropriately.
Act as a point of contact for site personnel, providing guidance on protocol requirements and regulatory expectations. Contribute to audit readiness, participate in sponsor and investigator meetings, and support recruitment and retention initiatives. For late-phase real-world studies, engage in chart abstraction and collaborate with medical and local teams to align with regional healthcare practices.
Requirements
- Hold a Bachelor’s degree or nursing qualification in a relevant discipline, or an equivalent mix of education and clinical research experience
- Demonstrate solid understanding of ICH-GCP and applicable regulatory standards
- Exhibit strong computer literacy and adaptability to clinical technologies and data systems
- Possess effective communication and interpersonal abilities
- Be available for up to 75% travel as needed
- Experience in oncology trials is advantageous
Benefits
- Career development and growth opportunities
- Access to technical and therapeutic training programs
- Supportive management and peer recognition initiatives
- Inclusive workplace culture that values authenticity
- Programs designed to recognize performance and contributions
- Commitment to shaping impactful healthcare solutions
