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 summary.
5+ Years' Experience Level.
Top Skills Looking For
5 years CRA Experience-
Must Be able to work Onsite (San Diego)
(Mostly CA but could be other locations as well)
Science Degree
Previous Site Monitoring Experience, prefers candidate to have Medical Device or Pharmaceutical Background
Good communication and Org Skills plus detail oriented
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Human Resources Services
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