Imaging Research Associates

Feladatok

• Primary Responsibilities
• The Imaging Research Associate I, coordinates all site and operational activities, from study start to study close, to ensure the timely delivery of high quality service deliverables for assigned studies.
• Assist in preparation and reproduction of study materials during study start-up phase of clinical trials
• Follow up with outstanding documentations from clinical sites to complete site qualification
• Schedule logistical and technical trainings with site personnel
• Create test run requests for sites submitting digital data
• Review, process, track and monitor all study related data received from sites
• Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management
• Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors
• Investigate and complete logistical edit checks
• Report issues found with study systems (i.e. study database, reading analysis system)
• Perform day to day IQC activities including coordinating, requesting, tracking and processing of IQC data including:
• Baseline, on-going, and end/interim analysis IQC Data Review
• Coordination of cross calibration phantom rotation
• Phantom data analysis and data entry
• Ensuring accuracy of tracking information in IQC Tracking and study tracking databases as pertaining to IQC and/or DXA scanner information
• Coordinating machine change instances for appropriate documentation and equivalence data collection
• Machine Equivalence analysis and processing
• Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements
• Manage Baseline, Interim and End of Study IQC data submissions, track and report progress to study teams and ensure timelines are met
• Communicate with Bioclinica clinical study team and/or sponsor regarding deliverables
• Understand functions of software used to produce and collect IQC data
• BMD Scan Review Form preparation
• Study database maintenance (e.g., change of contact information)
• Assists Project Managers with project administration by
• Planning and coordinating the site start-up activities
• Reading and understanding project protocol documents
• Entering, maintaining, and tracking of data in internal software
• Participating in project meetings, conference calls, and training calls
• Assists Project Managers in maintaining, reviewing and communicating project progress by
• Reviewing and analysing project tracking weekly
• Generates, tracks and resolves data queries
• Identifying site and data trends, and recommending actions to Project Manager
• Communicating and following up on project tracking discrepancies
• Assisting in monitoring data flow
• Generating, reviewing and distributing weekly/monthly project tracking reports
• Ensures the development and adherence to project timelines as they relate to therapeutic processes by
• Following up on outstanding items including missing data, incomplete paperwork, etc.
• Managing site communication, including distribution of subject data reports
• Assisting in tracking and resolving of client issues
• Scheduling and tracking completion of site training
• Serving as an additional point of contact to client, sites, sponsors, etc.
• Keeping supervisor advised of current issues
• Maintains client (internal and external) satisfaction by
• Responding to inquiries in a professional, courteous and timely manner
• Maintains Quality Service and Departmental Standards by
• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
• Assisting in establishing and enforcing departmental standards
• Participating in the modification of company SOPs related to the therapeutic team
• Maintains Technical and Industry Knowledge by
• Attending and participating in applicable company-sponsored training

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