Research Analyst

• You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Clinical Research Associate II

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Verifies issues or risks associated with blinded or randomized information related to IP
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
• Reconciles contents of the ISF with the Trial Master File (TMF)
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt to changing priorities to achieve goals / targets
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• May provide training or mentorship to more junior level CRAs

Senior Clinical Research Associate – Sponsor Dedicated

• Prepare and reproduce study materials during start-up
• Follow up on site documentation and schedule training sessions
• Create test run requests and review incoming study data
• Monitor and resolve data discrepancies and manage site communications
• Generate and verify reports for sites and sponsors
• Investigate logistical edit checks and report system issues
• Coordinate and process IQC data including phantom rotation and machine equivalence
• Maintain IQC tracking databases and ensure protocol compliance
• Track IQC submissions and communicate progress to study teams
• Maintain study databases and prepare BMD Scan Review Forms
• Plan and coordinate site start-up activities and training
• Enter and track data in internal systems and participate in project meetings
• Review project tracking, resolve queries, and identify site/data trends
• Manage site communications and assist with client issue resolution
• Respond to inquiries professionally and maintain SOP compliance
• Participate in SOP updates and company-sponsored training

Imaging Research Associate I

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects
• Responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management
• Monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices
• Act as primary liaison between CRAs and project team
• Participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools
• Represent the corporation by maintaining collaborative relationships with stakeholders

Senior Clinical Research Associate – Hungary

• Implement and manage global research projects
• Development of research designs and survey documents
• Brief and manage market research agencies
• Analyze and interpret survey results and prepare them for the various internal stakeholders in the company, e.g. Marketing, PR, Product & Category Management, Sales, Management
• Analysis of the existing product categories to map their size and competitive situation
• Help identify category, shopper and channel insights and trends to create foresight
• Work closely with our 30+ subsidiaries and functions to understand market and category trends

Research Analyst jobs in Hungary

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Clinical Research Associate II

Clinical Research Associate II

Senior Clinical Research Associate – Sponsor Dedicated

Imaging Research Associate I

Senior Clinical Research Associate – Hungary

Global Market Research Specialist