Clinical Research Associate II, Senior, PCRA

🔥 6 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 25 days.
• No salary listed.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis, and corrective/preventive actions • Ensure data accuracy through source data review, source data verification, and CRF review • Assess investigational products through inventory and records review • Document observations in reports and letters • Escalate deficiencies and track issues through resolution • Maintain contact with investigational sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and properly maintained • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical study systems, including Clinical Trial Management Systems • Facilitate communication among investigational sites, clients, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Assist with project publications and tools, contribute ideas, and support process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience comparable to 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic areas and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk-Based Monitoring concepts and processes • Good oral and written communication skills • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time-management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Solid Microsoft Office skills and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel independently up to 80% by automobile, airplane, and train • Ability to work in non-traditional work environments and use standard office equipment and technology

🏖️ Benefits

• Health and well-being support • Accessibility service and disability accommodations for the application process • Full-time employment • Fully remote work arrangement • Global team and mission-driven work environment

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume