Senior Clinical Research Associate – FSP

🔥 0 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

🧪 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 required clinical trial documentation and sponsor/monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable 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 SDR, SDV and CRF review during on-site and remote monitoring • Assess investigational product inventory and records • Document observations in reports and letters using approved business writing standards • Escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans and participate in investigator payments • Track trial status, provide progress updates to the CTM and update CTMS systems • Perform CTMS report quality-control checks when required • Participate in investigator meetings and identify potential qualified investigators • Initiate clinical trial sites and ensure trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Support project publications/tools, team initiatives and additional CTM-assigned study tasks • Facilitate communication among investigative sites, client company and PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field or a 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 where applicable • An equivalency combining appropriate education, training and/or directly related experience may be considered • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application 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 • Effective oral and written communication skills with medical personnel • Customer focus, listening skills and attention to detail • Interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Excellent Hungarian language and grammar skills • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to lift 40 lbs. without assistance • Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information