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Clinical Research Associate II

2 months ago

Montreal, Quebec, Canada Innovaderm Research Full time
Job Title: Clinical Research Associate II

Join our team at Innovaderm Research as a Clinical Research Associate II, where you will play a crucial role in the success of our clinical trials. As a key member of our team, you will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

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, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
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 working in a phase 1 unit or monitoring phase 1 studies an asset
  • Good knowledge of ICH/GCP standards and applicable regulatory requirements
  • Strong verbal and written communication skills in English
What We Offer:
  • Flexible work schedule
  • Remote - Traveling position -
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Ongoing learning and development