Job Details

  • Title: Study Assessment Planning Associate
  • Code: RCI-33635-1
  • Location: Lawrenceville New Jersey (NJ) 08648
  • Posted Date: 11/18/2020
  • Duration: 12 Months
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  Job Description

Must have:

  • Comprehensive understanding of clinical trial operations, including PK, PD, Laboratory Safety testing, and additional protocol assessments terminology.
  • Knowledge of clinical design trial
  • Understanding of Time and Event tables captured in clinical trial protocols
  • Ability to proactively identify issues, make decisions, and resolve problems
  • Demonstrates a strong understanding of the overall project goals and deadlines

Nice to have:

  • Knowledge of general clinical research including Investigator site processes, site operations
  • Knowledge of the pharmaceutical industry including the clinical and regulatory components.
  • Background in QC
  • Experience in robust data review
  • Experience in protocol authoring
  • Understanding of sample handling management, collection and testing tube experience, and shipping logistics
  • Management of clinical trial activities during study start up and execution
  • Reviews the clinical protocol to identify study design, planned Assessments, and details of time and event schedules
  • Provides assistance to ensure data quality and integrity for historical and on-going company’s trials
  • Manages metadata required at a protocol level
  • Data review responsibilities for assessment and visit matrix alignment
  • Can manage working on multiple studies at any given time
  • Drives and owns timelines for assigned projects
  • Assists with development data quality for company’s clinical trial database
  • 3 + years of clinical trials in a pharma research or central clinical lab organization
  • Project Management, excel is desirable
  • Bachelor’s Degree required - B.S. A degree in Life Sciences or equivalent is preferred