CRA II

🕒 5 days ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 10%

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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 clinical trial documentation and sponsor-specific procedures • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis and problem-solving to identify process failures 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 in reports and letters, escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and investigator meetings • Investigate and follow up on findings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and available • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as CTMS • Facilitate communication between investigative sites, client companies and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to project publications, tools, process-improvement initiatives and other project work

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Approximately 1 year of experience as a clinical research monitor • Valid driver's license where applicable • Proven clinical monitoring skills • Knowledge 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 • Organizational and time management skills • Effective interpersonal skills and attention to detail • Flexibility and adaptability • Ability to work independently and in a team • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, with the role stating a travel requirement over 75% • Ability to work in office, laboratory, clinical and/or home office environments • Ability to comply with sponsor/client/site requirements • Ability to perform required physical activities, including prolonged standing or sitting, frequent mobility, bending, twisting, crouching and light to moderate lifting • Ability to perform under stress and multitask • Regular and consistent attendance

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule • Home office environment option • Travel expenses likely associated with required business travel (not explicitly stated as a benefit)

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