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.
Note
Backfilled Role-Notes in Place of Spotlight
Top Skills looking for:
ONSITE POSITION- MUST BE LOCAL TO SAN DIEGO
5 years CRA Experience-
Must Be able to work Onsite (San Diego)
Travel can be up to 30 %-
(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
Hello suppliers please note when submitting if your candidate is local to the San Diego CA area.
This is an onsite role in San Diego.
She does not want anyone that will have to relocate (unless it is from the area and just moves closer) no cross country moves.
She is reviewing candidates and scheduling interviews so please make sure your submitted candidates can commit to this onsite position before submittals
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Human Resources Services
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