26 Oct
|
Premier Research Group
|
Canada
26 Oct
Premier Research Group
Canada
Senior Clinical Research Associate (Canada)Apply: Remote: Canada: Part time: Posted 18 Days Ago: R6995Premier Research is looking for a Senior Clinical Research Associate (Canada) to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
* We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
* As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
What You’ll Be Doing:* Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records.
* Issues, investigates, and resolves any data discrepancies identified during source verification activities.
* Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
* Performs budget negotiations with clinical trial sites.What We Are Searching For:* Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience.
* 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Experience in Phase 1 studies
* Fluent in English and French
* Must be located in Ontario or Quebec, Canada
* Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities.
* Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.This is a part-time 6-month contract position with the potential to extend.**### Premier Research is more than a company
- it’s a community furthering research to improve the lives of patients in critical need. Our Values
- We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care
- mirror the determination, flexibility and trust that our team embodies.
* Our dedication to biotech and specialty pharma is unlike any other.
* We provide our staff with cutting-edge technologies and continuous learning. #
📌 Remote Clinical Research Associate (Canada)
🏢 Premier Research Group
📍 Canada