Clinical Research Associate (CRA) Jobs
San Diego, CA
Title: Clinical Research Associate
Country
Description
- Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 - 50% travel) for GCP compliance according to SOPs and/or client guidelines
Recruit investigators for participation in clinical trials Negotiate study budgets with investigators
- Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
-Review draft protocols for completeness and feasibility
-Develop Case Report Forms for clinical trials Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators Meetings
-Prepare and process Serious Adverse Event (SAE) reports Prepare project management reports for clients, project personnel, and management
-Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries Resolve queries of CRF data with study site personnel
-Review Tables and Listings generated from study data .Assist in writing Clinical Study Reports, with supervision??
-Bachelors degree or RN
-Two years work experience in clinical research, data management, regulatory affairs or other relevant healthcare research position. In lieu of this work experience, those with an applicable doctoral degree (eg, PhD,
-Effective written and verbal communication skills
-Ability and willingness to travel up to 50%
-Excellent organizational skills
-Ability to manage time and work independently
Must have experience in one of the following therapeutic areas -Oncology, Neuroscience, Cardiovascular, or Infectious Disease
