Senior CRA – Level I

🔥 1 hour ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 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 sponsor procedures, guidelines and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Protect subjects' rights and well-being and ensure data reliability • Maintain audit readiness and 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 source document review, source data verification and case report form review • Assess investigational products through inventory and records review • Prepare timely reports and letters documenting observations • 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 • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform required quality-control checks • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and support trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools and other study tasks • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Contribute to project work and 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 • Minimum of 3 years of completed on-site clinical monitoring experience • Experience in infectious disease (pneumonia), respiratory, ophthalmology and oncology clinical studies is preferred • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated 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 • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently and 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 possible vaccination-status or other personal-information disclosures • Ability to travel frequently, generally 60–80%, including extended overnight stays • Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Frequent travel expenses likely associated with site visits • Professional development through participation in project publications, tools, process-improvement initiatives, and team calls

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