Clinical Research Associate II, Calgary, Alberta Position

4 days ago


Calgary, Alberta, Canada Innovaderm Research Full time

Clinical Research Associate II Job Overview

The Clinical Research Associate II will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Key Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations
  • Participate in investigators' meetings
  • Prepare site visit reports and follow-up letters to the investigator
  • Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
  • Perform source data verification, ensure on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate

About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. Our organization has a solid reputation for the quality of its research and services exceeding the expectations of its clients. We are committed to providing equitable treatment and equal opportunity to all individuals.

Requirements

  • Bachelor's degree in a field relevant to clinical research, nursing degree and/or equivalent experience
  • 1-3 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
  • Experience in dermatology is an asset
  • Good knowledge of ICH/GCP standards and applicable regulatory requirements
  • Strong verbal and written communication skills in English


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