Sr CRA

📋 Description

• • Conducts site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), protocols, and company SOPs.
• • Verifies that informed consent processes are properly documented for all subjects/patients and ensures confidentiality and data integrity at investigator sites.
• • Performs source document review and data verification against case report forms (CRFs), resolving queries remotely and on-site within agreed timelines using electronic data capture systems.
• • Manages investigational product (IP) inventory, reconciliation, storage, and security; confirms IP is dispensed and administered per protocol and complies with labeling, import, and return regulations.
• • Reviews and maintains the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconciles ISF contents with the Trial Master File (TMF) and ensures adherence to local archiving requirements.
• • Documents all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with SOPs and Clinical Monitoring/Site Management Plans.
• • Supports subject recruitment and retention strategies, enters tracking data into systems to monitor site status and action items to resolution.
• • Manages site-level activities to align with project scope, budgets, and timelines; adapts quickly to changing priorities to meet deliverables and milestones.
• • Serves as primary liaison between sponsor and site personnel, ensuring all site staff are trained and compliant with regulatory and protocol requirements.
• • Prepares for and participates in Investigator Meetings and global clinical monitoring/project meetings, including those with sponsor representation.
• • Ensures sites are audit-ready and supports preparation for and follow-up of regulatory audits.
• • Provides mentorship and training to junior CRAs, including conducting training and sign-off visits as assigned.
• • For Real World Late Phase (RWLP) roles: Supports sites throughout the entire study lifecycle from identification to close-out; performs chart abstraction and data collection; collaborates with sponsors, medical science liaisons, and local country staff; identifies potential sites based on local treatment patterns and HCP associations; develops country-specific informed consent forms; collaborates with RWLP Regulatory team to apply updated regulatory information; participates in bid defense meetings.
• • Applies knowledge of local regulations and organizational procedures to ensure compliance across all monitoring activities.
• • Uses judgment and experience to evaluate site performance, escalate serious issues to the project team, and develop corrective action plans.
• • Maintains current knowledge of ICH/GCP guidelines, applicable regulations, and evolving industry standards.
• • Demonstrates proficiency in using clinical trial software, electronic data capture tools, and other relevant technologies to support study execution.