Clinical Trial Associate

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Clinical Trial Associate

Clinical Trial Associates play an important part in the clinical trial process.  As a key member of the clinical affairs team, the Clinical Trial Associate or Clinical Trial Coordinator is responsible for the successful execution of late stage drug clinical trials from study start-up to close-out.  The right candidate will be responsible for compiling, reviewing, receiving, and distributing key study related documents such as study protocols, FDA form 1572, IRB submission forms, source document worksheets, informed consents, regulatory binder logs, etc.


  • Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials
  • Assist in management of TMF to meet aggressive timelines
  • Assist with the auditing and reconciliation of all study related documents for trials
  • Coordinate logistics for clinical project meetings
  • Develop knowledge and expertise in therapeutic area
  • Ensure timely completion of study tasks and update trial trackers on an on-going basis
  • Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
  • Generate and distribute internal and external newsletters
  • Maintain version and quality control of study documentation and submit to TMF
  • Proactively identify and resolve clinical study issues
  • Top of form
  • Track and qualify interested investigators

Job Requirements:

  • 2 years of relevant hands-on drug experience in CRO or sponsor setting
  • Bachelor’s degree
  • Excellent communication (oral and written), organizational, and problem solving skills
  • Excellent Microsoft Office skills
  • High energy individual able to effectively multi-task and strive in a dynamic start-up environment
  • Strong attention to detail
  • Strong knowledge of ICH-GCP guidelines and other regulatory requirements clinical trial management

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