|新着求人 モニター (MM-42)|
|募集職種||外資系製薬企業の Sr. Clinical Trial Monitor
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies)
• Recommends sites during the site feasibility and/or site selection process
• Conducts pre-study visit as appropriate
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, ＊＊ procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
• Serve as a point of contact for Sites
• Provides trainings to sites
• Performs site closure activities when all required protocol visits and follow-up are completed
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.
• Oversees activities of site personnel over whom there is no direct authority.
• Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
• May support Ethics Committee submission, ICF review, collection of documents to/from site
• May support ensuring access to eDC and ＊＊ / vendor systems is available for clinical trial site personnel
• May support equipment calibration and tracking
• May support preparation of Study Initiation Visit materials
• May support coordination and ensure database lock timelines are met as required locally
【Senior Level Expectations】
• Proactively identify and resolve potential problems at both site and country level.
• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
• Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
• Contribute significantly to study team and coaches site staff to enhance site and hub performance.
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
• May assist line management with conducting monitoring authorizations and ongoing assessments