Job Description

Job Location:
Bakersfield, CA

Experience:

MS in Clinical Research +1 yrs experience or BS in Clinical Research +5 yrs of experience

Qualification:
Onsite monitoring experience mandatory

Job Responsibilities:

• Overall site management of clinical trials ensuring that projects are progressing according to contract, defined quality standards, protocols, SOP’s, GCP and other applicable guidelines
• Prepare project scope of work, timeline, project goals, technical information
• Prepare site visits, Site Qualification, Site Initiation, Site Monitoring, Site Closeout, Risk Analysis, monitoring plan, Quality Management
• Monitoring trial conducting sites, ensure human rights are not violated, source data verification, collecting completed CRFs from sites, IP accountability, creating monitoring reports
• Ensure Site closeout, resolve data queries, availability of updated site files, patient file, reconciliation of Investigational product, ensure project is archived
• Maintain trial master file throughout study period, including but not limited to report AEs, annual IRB reports, IRB communications, and CBCC correspondence