Clinical Research Associate
1 week ago
Job Description:
">We are seeking an experienced Clinical Research Associate to join our team as a Senior Clinical Research Associate - Regional. In this role, you will be responsible for providing site management and support to external trial staff from trial initiation to closeout.
">Responsibilities:
">- ">
- Provide site management and support to external trial staff">
- Ensure collection of high-quality data, timely adverse event reporting, subject protection, and compliance to the protocol">
- Adhere to ICH-GCP, Canadian regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines">
- Manage recruitment and retention strategies at the site level">
- Collaborate regularly with Local Trial Manager and Line of Business Manager">
- Train and support external trial staff regarding requirements for CRF and IVRS data entry">
- Identify objectives for scheduled monitoring visits">
- Prepare and complete monitoring visit reports and follow-up letters">
- Proactive use of EDC and other data source systems">
- Identify potential risks and proactively prevent or mitigate them">
- Participate in Sponsor and Regulatory audits">
Requirements:
">- ">
- Bachelor's degree required">
- 4+ years of CRA (monitoring experience) ideally 5+ years of field CRA monitoring experience">
- 6+ years of clinical research industry experience">
- Diabetes experience is a nice to have">
- Remote Monitoring Experience">
- Risk-Based Monitoring experience">
- Flexible and agile">
- Comfortable with travel from Newfoundland to Saskatchewan">
- Complex trial experience">
- Bilingual French/English">
Working Conditions:
">- ">
- Works from a home office environment at least one day a week">
- Works at hospitals, medical clinics three to four times a week">
- May be required to drive, fly, or take train to location to perform duties of the job">
- Up to 70% travel required">
Benefits:
">- ">
- Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans">
- 401(k) plan participation">
About Us:
">System One is a leading provider of clinical research services. We pride ourselves on our commitment to excellence and our ability to deliver high-quality results.
">Apply Now:
">To apply for this exciting opportunity, please submit your resume and cover letter. We look forward to hearing from you
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