Clinical Trial Monitoring & Oversight

• Independently conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV)

• Ensure investigational sites comply with study protocols, ICH-GCP, applicable regulations, and sponsor requirements

• Verify subject safety, informed consent, and accurate source documentation

• Perform source data verification (SDV) and ensure data quality and integrity

Site & Investigator Management

• Serve as the primary point of contact for assigned investigative sites

• Build strong relationships with investigators, site staff, and vendors

• Identify site performance issues and implement corrective and preventive actions (CAPA)

• Support site staff training on protocol, EDC, and trial procedures

Study Startup & Execution

• Support site feasibility, site selection, and startup activities

• Ensure regulatory documents are collected, reviewed, and maintained in the eTMF

• Facilitate timely site activation and first patient enrollment

• Monitor enrollment, retention, and protocol adherence

Data Quality & Systems Management

• Review and resolve EDC queries in collaboration with sites and data management

• Ensure timely and accurate data entry and database readiness

• Maintain oversight of essential documents in eTMF systems

• Ensure compliance with monitoring plans and risk-based monitoring (RBM) strategies

Regulatory Compliance & Documentation

• Ensure regulatory binders and trial master files are inspection-ready at all times

• Support internal audits, regulatory inspections, and health authority queries

• Prepare accurate monitoring visit reports and follow-up letters within required timelines

Cross-Functional Collaboration

• Collaborate with Clinical Trial Managers, Project Managers, Data Management, Safety, and Regulatory Affairs teams

• Participate in investigator meetings, study team meetings, and training sessions

• Provide subject matter expertise and contribute to continuous process improvement

Leadership & Mentorship

• Mentor junior CRAs and support CRA onboarding and training

• Contribute to study planning, risk assessment, and monitoring strategy development

• Act as a subject matter expert (SME) for assigned studies or therapeutic areas