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In this position the candidate will be wearing two hats. One will be as a study coordinator where Alameda functions as a “clinical site” and the coordinator would be recruiting and enrolling subjects, explain the risks, conducting a clinical study, etc. and this will be done under ...

Job Description

  • In this position the candidate will be wearing two hats.
  • One will be as a study coordinator where Alameda functions as a “clinical site” and the coordinator would be recruiting and enrolling subjects, explain the risks, conducting a clinical study, etc. and this will be done under the oversight of a principal investigator.
  • The other hat is the study monitor.
  • This part of the role, the candidate will review and monitor the study data, collecting the information and writing monitoring reports.
  • The biggest difference between this position and others, is that the candidate will not travel to sites to monitor the study and data but will be doing so at the Alameda site.
  • Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.
  • Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
  • Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study
  • 0-3 Years Experience Level.