Senior Clinical Research Associate

📋 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 dispensing and administration align with protocol requirements and regulatory standards.
• • Reviews and maintains the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconciles ISF contents with the Trial Master File (TMF) and ensures proper archiving per local regulations.
• • Documents all monitoring activities through trip reports, confirmation letters, 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 meet project timelines, budgets, and deliverables; adapts quickly to shifting priorities and evolving study requirements.
• • 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, sponsor meetings, and clinical training sessions; may lead global clinical monitoring or project team meetings with sponsor representation.
• • Ensures sites are audit-ready and supports preparation for regulatory audits, including follow-up on audit findings and corrective actions.
• • Provides mentorship and training to junior Clinical Research Associates (CRAs); conducts training and sign-off visits for less experienced staff 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 in alignment with local regulatory requirements; collaborates with RWLP Regulatory teams to ensure updated regulatory information is applied and shared.
• • Participates in bid defense meetings and applies knowledge of local requirements for real-world late-phase study designs.
• • Maintains up-to-date knowledge of ICH/GCP guidelines, applicable regulations, and company processes to ensure consistent compliance across all assigned sites.
• • Uses judgment and experience to evaluate site performance, identify risks related to protocol deviations, pharmacovigilance issues, and blinded/randomized information, and escalates serious concerns to the project team.
• • Applies critical thinking to resolve complex site issues and drives timely resolution of data discrepancies and compliance gaps.