Senior CRA – Level I

🕒 September 29

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 11%

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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 clinical monitoring and site-management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation, sponsor procedures and monitoring guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure subject rights, well-being, data reliability and audit readiness • Build collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root-cause analysis and corrective/preventive actions • Ensure data accuracy through source-document review, source-data verification and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between visits and conduct monitoring according to approved plans • Participate in investigator payment processes • Track trial status, provide progress reports to the Clinical Team Manager and update study systems/CTMS • Perform CTMS report quality-control checks when required • Participate in investigator meetings and identify qualified investigative sites • Initiate clinical trial sites and ensure trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications/tools and additional study tasks such as trip-report review, newsletter creation and leading CRA team calls • Facilitate communication among sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor • Valid driver's license where applicable • Equivalent combination of 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 • Effective interpersonal skills and strong attention to detail • 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 • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including vaccination-status or other personal-information disclosures where required • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, clinical and/or home-office environments and use required personal protective equipment

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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