SCRA I

📋 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), and study protocols.
• • 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 of medical records and verifies accuracy and completeness of clinical data entered into case report forms (CRFs) through remote and on-site data validation.
• • Applies query resolution techniques to address data discrepancies and guides site staff to resolve queries within agreed timelines, utilizing electronic data capture systems.
• • Monitors investigational product (IP) inventory, reconciliation, storage, and security; confirms IP is dispensed and administered per protocol and verifies compliance 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 via confirmation letters, trip reports, communication logs, and other required project documentation in accordance with SOPs and Clinical Monitoring/Site Management Plans.
• • Supports subject recruitment and retention strategies and 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 the sponsor and site personnel, ensuring all site team members are trained and compliant with regulatory and company requirements.
• • Prepares for and participates in Investigator Meetings and sponsor-facing clinical meetings; may lead global clinical monitoring meetings with sponsor representation under supervision.
• • Ensures sites are audit-ready and supports preparation for regulatory audits, including follow-up on required corrective actions.
• • Provides mentorship and training to junior Clinical Research Associates (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, patient advocacy networks, and Health Care Provider (HCP) associations; suggests operational efficiencies and process improvements.
• • Develops country-specific informed consent forms and collaborates with RWLP Regulatory teams to ensure regulatory updates are applied and communicated.
• • Participates in bid defense meetings and demonstrates knowledge of local requirements for real-world late-phase study designs.
• • Maintains current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs; applies judgment to evaluate site performance and escalate serious issues promptly.
• • Uses computer systems and software to support clinical data review, capture, and tracking; demonstrates proficiency in technology adoption.
• • Travels up to 75% of the time to conduct on-site monitoring activities as required by study needs.