Clinical Research Associate II

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial close-out and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • Facilitate communication between investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications/tools and contribute ideas • Contribute to project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life science related field or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 2 years as a clinical research monitor • Valid driver's license • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge 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 • Organizational and time management skills • Good computer skills, including Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to work in a team or independently • Ability to remain flexible and adaptable • Frequent travel to site locations

🏖️ Benefits

• Frequent travel, generally 60-80% but more for some individuals, with possible extended overnight stays • Personal protective equipment provided/required, including protective eyewear, garments and gloves