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Clinical Trial Administrator II


Waltham, Massachusetts
  • Healthcare
  • Monitoring
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  • Research Salary

Job Details

At CROMSOURCE, Clinical Trial Administrators (CTA) are key players in the success of our clinical trials. As a CTA you have the opportunity to be the main avenue of support for the clinical trial team. The CTA cooperates with the project team with accurately updating and maintaining clinical tracking systems as well as being responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP's.

Main Job Tasks and Responsibilities

  • Keeps him/herself professionally abreast of all regulatory and operative aspects relevant to the clinical projects he/she will be assigned
  • Should be knowledgeable, following appropriate trainings, in the application process for clinical studies, in force in the country of work. Accordingly he/she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant
  • Prepares and requests the necessary local authorities approvals schedule
  • Oversees and manages the agreements with hospitals and investigational centers
  • Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project)
  • Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
  • Collaborates with the project team in organizing Investigator's and Monitor's Meetings
  • Collaborates with the project team in managing the follow-ups of the monitor's activities
  • Manages the telephone monitoring of projects
  • Oversees and manages the payments of sites
  • Collaborates in complying and enforcing Company procedures

Must have experience:

  • Bachelor's degree
  • At least 5 years of Clinical Research experience in the CRO/Pharmaceutical industry
  • Good Knowledge of clinical trial operations, ICH/GCP Guidelines and other applicable regulatory requirements
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willing to be a flexible, well organized part of the team!
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