• Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Regional Clinical Research Associate

Job Number: 31997

Location: Remote, 

Job Description

The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.


  • Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit.  This may include the following site visits: qualification, initiation, interim, and close out
  • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
  • Monitoring and documenting investigational product dispensing, inventory, and reconciliation
  • Monitoring and documenting laboratory sample storage and shipment
  • Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
  • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
  • Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
  • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
  • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
  • Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

Required Skills

  • Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
  • 2+ years of prior experience as a Clinical Research Associate, 4+ years for Senior CRA 
  • Site monitoring experience is required


Apply for job

To apply for this job please visit k7y.pl.