CRA II - Multi Sponsor

📋 Description

• • Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.
• • Verify proper documentation and execution of informed consent for all subjects/patients, ensuring confidentiality and protection of patient rights.
• • Conduct source document reviews and verify accuracy and completeness of clinical data entered into case report forms (CRFs), applying query resolution techniques both remotely and on-site.
• • Monitor and ensure compliance with electronic data capture systems and validate site adherence to required digital protocols.
• • Manage investigational product (IP) inventory, reconciliation, storage, and security; confirm IP dispensing and administration align with protocol and verify blinded/randomized information integrity.
• • Review and reconcile Investigator Site File (ISF) contents with the Trial Master File (TMF), ensuring timely, accurate, and complete archiving of essential documents per local regulations.
• • Document all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with SOPs and Clinical Monitoring/Site Management Plans.
• • Support subject recruitment and retention strategies, entering data into tracking systems to monitor site status, observations, and action items to resolution.
• • Manage site-level activities within project scope, budgets, and timelines, adapting quickly to shifting priorities to meet deliverables and deadlines.
• • Serve as primary liaison between study sites and the project team, including collaboration with Central Monitoring Associates, ensuring site staff are trained and compliant.
• • Prepare for and attend Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings, including participation with Sponsor representatives.
• • Ensure sites are audit-ready by providing guidance on compliance standards and supporting preparation for and follow-up of regulatory audits.
• • Maintain current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs; complete all required training promptly.
• • For Real World Late Phase studies, perform chart abstraction and data collection, support site identification through close-out, and collaborate with Sponsor affiliates, medical science liaisons, and local country staff.
• • Proactively identify potential sites based on local knowledge of treatment patterns, patient advocacy networks, and Health Care Provider (HCP) associations.
• • May train junior staff and communicate out-of-scope activities to Lead CRA or Project Manager.
• • Travel up to 75% regularly to conduct on-site monitoring activities as required by study protocols and operational needs.