Responsibilities
- Manages end-to-end site operations to safeguard patient safety and ensure high-quality data with minimal discrepancies and strong audit outcomes.
- Guides sites and project teams on audit preparedness, including supporting audit preparation and follow-up activities.
- Maintains and updates trial management systems, tools, and status tracking documentation throughout the study lifecycle.
- Coordinates site initiation activities when needed, including feasibility assessments, investigator recruitment, ethics submissions, regulatory document collection, informed consent review, translations, and required notifications.
- Supports budget discussions and investigator contract execution under guidance from contract management teams.
- Confirms that informed consent procedures are properly conducted and documented for each participant as required.
- Evaluates site-level risks affecting participant safety and data validity, including protocol deviations and safety reporting issues.
- Conducts all types of monitoring visits independently, including pre-study, initiation, routine, and close-out visits, following protocol, ICH-GCP, and organizational procedures.
- Produces and submits accurate, timely monitoring reports for both on-site and remote visits.
- Records all activities through required documentation such as confirmation letters, follow-up communications, trip reports, and logs per SOPs and project plans.
- Supports strategies to enhance participant recruitment, retention, and study awareness.
- Enters observations, action items, and status updates into tracking systems for resolution monitoring.
- Regularly audits the Investigator Site File for completeness, accuracy, and timeliness.
- Aligns the Investigator Site File content with the Trial Master File to ensure consistency.
- Ensures sites follow local regulations for archiving essential study documents.
- Communicates proactively with site staff and internal project teams to report study issues, protocol deviations, and implement corrective actions.
- Builds and maintains strong relationships with investigators and site personnel, representing organizational standards and professionalism.
- Conducts inventory checks, reconciliation, and reviews storage and security measures for investigational products.
- Verifies that investigational products are dispensed and administered in compliance with the study protocol.
- Monitors for risks related to blinded or randomized treatment assignments involving investigational products.
- Applies knowledge of GCP and local regulations to ensure proper labeling, importation, release, and return of investigational products.
- Performs remote data reviews, including EDC and patient profile checks, resolves queries, and supports data quality resolution efforts.
- Identifies and processes Serious Adverse Events according to established study procedures.
- Demonstrates thorough understanding of SAE reporting requirements and timelines.
- Recognizes potential site risks and escalates them to management with proposed mitigation strategies.
