Clinical Research Associate II, Calgary, Alberta Position
4 weeks ago
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 continue to grow and expand in North America and Europe.
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
- Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
- Excellent judgement and problem-solving skills
- Travel to research sites approximately 65% of the time
- Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
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Calgary, Alberta, Canada Innovaderm Research Full timeJob Title: Clinical Research Associate IIWe are seeking a highly skilled Clinical Research Associate II to join our team at Innovaderm Research. As a Clinical Research Associate II, you will play a critical role in the success of our clinical trials by ensuring that research sites are qualified, initiated, monitored, and closed out in accordance with the...
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Calgary, Alberta, Canada Innovaderm Research Full timeClinical Research Associate II Job OverviewThe 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...
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Calgary, Alberta, Canada Innovaderm Research Full timeClinical Research Associate II Job OverviewThe 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...
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