Clinical Research Associate - CRA (regional-home based)

 

Exciting permanent opportunity with one of the fastest growing International Clinical Research Organizations in the country. CRA's with 2-3 year of oncology monitoring experience desired.

  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


Requirements

· Bachelor’s degree or RN - must have 2 years minimum Oncology monitoring
· Six months’ 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, PharmD, MD) will be considered
· 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