CRAII/Sr CRA (Sponsor dedicated) Czech

📋 Description

• • Conducts on-site and remote site qualification, initiation, interim monitoring, and close-out visits to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), protocol requirements, and company SOPs.
• • Verifies that informed consent processes are properly documented for each subject/patient and ensures confidentiality and protection of subject/patient data throughout the study lifecycle.
• • Performs source document review of medical records and site documentation to verify accuracy and completeness of clinical data entered into case report forms (CRFs), resolving queries remotely and on-site within agreed timelines.
• • Monitors and reconciles investigational product (IP) inventory, storage, security, dispensing, and administration in alignment with protocol and regulatory standards, including proper relabeling, import, and return procedures.
• • Reviews and maintains the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring alignment with the Trial Master File (TMF) and adherence to local archiving regulations.
• • Documents all monitoring activities through confirmation letters, trip reports, follow-up correspondence, and communication logs as required by SOPs and the Clinical Monitoring/Site Management Plan.
• • Supports subject recruitment and retention strategies, enters and updates tracking system data to monitor site status, observations, and action items to resolution.
• • Manages site-level activities to meet project objectives, timelines, and budgets, adapting quickly to changing priorities and evolving study requirements.
• • Serves as primary liaison between sponsor and site personnel, ensuring all site staff are trained and compliant with applicable regulatory and operational requirements.
• • Prepares for and participates in Investigator Meetings, sponsor-facing meetings, and global clinical monitoring/project team meetings, including representation of sponsor interests when applicable.
• • Ensures sites are audit-ready by supporting preparation for regulatory inspections and implementing required follow-up actions.
• • Provides mentorship, training, and supervision to junior CRAs, including conducting training and sign-off visits as assigned.
• • For Real World Late Phase (RWLP) studies, performs chart abstraction and data collection, collaborates with medical science liaisons and local country staff, and identifies potential sites based on local treatment patterns and HCP associations.
• • Develops study- and country-level informed consent forms in collaboration with regulatory teams, and contributes to Case Report Form design and edit check development.
• • Participates in bid defense meetings, Requests for Proposals (RFPs), scope and budgeting discussions, and develops site management strategies.
• • Identifies and communicates out-of-scope activities to Lead CRA or Project Manager, and proactively suggests operational efficiencies and process improvements.
• • Maintains current knowledge of ICH/GCP guidelines, local regulations, and evolving industry standards to ensure compliance across all monitoring activities.
• • Utilizes electronic data capture systems and other clinical trial technologies to support data review, capture, and site management activities.
• • Travels up to 75% of the time to conduct on-site monitoring visits as required by study protocols and sponsor needs.