Clinical Research Associate

4 weeks ago

Shanghai, Shanghai, China Clario Full time
Job Description

We are seeking a highly motivated Clinical Research Associate - Imaging to join our team at Clario.

About the Job

This is a full-time position responsible for coordinating site and operational activities, ensuring 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
  • 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)
Qualifications

To be successful in this role, you will need:

  • A High School Graduate or Associate/Bachelor's Degree in bioscience, computer science, information technology or related field preferred
  • Familiarity with PC-based computers and standard software packages including e-mail, word processors, Excel spreadsheets and databases
  • Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred
  • Knowledge of 'good clinical practices' preferred
  • Familiarity with network navigation and file saving conventions, including moving/copying files and folders
What We Offer

We offer a competitive salary of $60,000 - $80,000 per year, based on experience, plus benefits, including medical, dental, and vision insurance, 401(k) plan, and paid time off.

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