The CRA is responsible for the following:
Conducting site visits, including pre-study, initiation, monitoring and close-out;
Confirming adherence to all FDA, ICH-GCP and local regulations;
Ensuring the completion and collection of regulatory documents;
Performing data verification of source documents;
Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
Participating in budget negotiation and follow-up where applicable;
Assisting with data validation and query resolution;
Mentoring team members as required (responsibility and oversight increasing with seniority).
Qualifications:
A minimum of 2 years of monitoring experience in various oncology trials
An advanced level of oncology knowledge an advantage
Completion of a science-related Bachelor's degree
Excellent knowledge of medical terminology and clinical monitoring process
Experience with clinical trial information systems and various e/TMF systems
Ability to travel as required (frequency to be negotiated)
TO APPLY FOR THIS POSITION YOU MUST BE A FULL TIME RESIDENT OF CALIFORNIA,US AND HAVE THE RELEVANT RIGHT TO WORK.
