Last updated: August 17, 2026

Responsibilities

Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements.
Function as a primary liaison to clinical investigators/site staff.
Identify, qualify, initiate, monitor and close out clinical sites.
Co-monitor with CRO when issues arise with the site.
Assist in the selection and oversight of Contract Research organizations and other vendors.
Reviews adverse events and other data listings to identify issues with study conduct or compliance.
Assist with protocol and case report form development, drafts trail-related documents and operational procedures, collects regulatory documents, and maintains clinical files.
Requirements

Bachelors degree, preferably in the Life Sciences, or a minimum of 3 years clinical research experience; including 2 years site monitoring.
Experience with Phase I and/or bioequivalence studies and an understanding of GCP and ICH guidelines.
Must be willing to travel a minimum of 40% domestically/internationally as required.

Scientific case review

Scientific Case Review

Would you like to understand whether current clinical programs, recent research developments, or emerging approaches may be relevant to your individual situation?

Send your question to our scientific team. The NBScience head office in the United Kingdom coordinates inquiries across international network of medical centres, scientists, and specialised consultants.

  • Review of the information you provide
  • Relevant research and clinical program information
  • A clear response focused on your situation
What happens next? Send your question, receive a focused scientific review, and get a clear response about research and clinical programs relevant to your situation.
Your scientific review will be prepared by Dr. Helen Melnik,PhD , who has more than 25 years of experience in stem cell research and international clinical programs.

No obligation. Your question will be reviewed confidentially.

Educational and research information only. This service does not constitute medical advice, diagnosis, prescription, or a personalized treatment recommendation.


NBScience

contract research organization

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