CRA II - SCRA I

📋 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 that informed consent processes are properly documented for each subject/patient and safeguard patient confidentiality throughout the study lifecycle.
• • 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 is dispensed and administered per protocol and verify blinded/randomized information integrity.
• • Review and maintain the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconcile ISF contents with the Trial Master File (TMF) and ensure sites comply with local archiving regulations.
• • Document all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with company 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 changing priorities to meet deliverables and deadlines.
• • Serve as primary liaison between Syneos Health and study site personnel, ensuring site staff are trained and compliant with regulatory and protocol requirements.
• • Prepare for and attend Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings as required.
• • Guide sites toward audit readiness and support preparation for regulatory audits, including follow-up on required corrective actions.
• • Maintain current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs; complete all mandatory training as assigned.
• • For Real World Late Phase studies, perform chart abstraction and data collection, collaborate with Sponsor affiliates, medical science liaisons, and local country staff, and proactively identify potential sites based on local treatment patterns and 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.
• • Utilize hardware and software tools to support clinical data review, capture, and tracking, demonstrating proficiency with evolving technologies.
• • Ensure all activities align with Syneos Health’s commitment to patient safety, data integrity, and regulatory compliance across global clinical trials.