Careers

Clinical Trial Associate

Clinical Research – Santa Ana, CA
 

Description

​Cold Genesys, Inc. is a biopharmaceutical company focused on the development of cancer immunotherapies to combat cancer. We are currently conducting a Phase III oncolytic virotherapy clinical trial across the US. Our company is rapidly expanding our clinical development efforts and would like to onboard a Clinical Trial Associate to assist us in monitoring our ongoing Phase I-III clinical trials in the US and overseas. We are looking for motivated individuals who are passionate about clinical research to join us in our pursuit of bringing world-class cancer therapies to patients.


Responsibilities

  • Coordinating with investigator sites to ensure compliance with protocol and maintenance of patient safety
  • Performing clinical on-site monitoring at various site locations across the United States, may include initiation visits
  • Regulating the enrollment of new patients into the trial
  • Preparing submissions to the investigator sites’ IRBs and IBCs
  • Composing and completing submissions to the FDA and NIH
  • Functioning as a liaison between third party contractors and the investigator sites
  • Updating internet based monitoring programs in order to evaluate patient progress
  • Maintaining databases detailing patient response to treatment
  • Providing status reports and updates on the trial to executives in the company
  • Some travel required

 

Requirements

  • Research methods training

  • Educated to degree level (biological science, pharmacy or other health related discipline)

  • 1+ years of Laboratory or clinical trials experience

  • Administrative Office experience

  • Authorized to work in the US


Bonus Points

  • Courses and knowledge of physiology, microbiology, and immunology are highly recommended