Imaging Research Associate I

4 weeks ago

Shanghai, Shanghai, China Clario Full time
Job Summary

The Imaging Research Associate I coordinates all site and operational activities to ensure timely delivery of high-quality service deliverables for assigned studies.

Key Responsibilities
  • 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
  • Ensure accuracy of tracking information in IQC Tracking and study tracking databases as pertaining to IQC and/or DXA scanner information
  • Coordinate 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)

Assist 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

Assist Project Managers in maintaining, reviewing and communicating project progress by

  • Reviewing and analyzing 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 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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