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 required clinical trial documentation and sponsor-specific procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, 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 • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform quality-control checks of CTMS reports • Participate in investigator meetings and identify potential investigators with client companies • Initiate clinical trial sites and make recommendations regarding site acceptability • Ensure trial closeout and retrieval of trial materials • Maintain complete essential documents and conduct on-site file reviews • Support preparation of project publications and tools and contribute to process improvements • Perform additional study tasks assigned by the Clinical Team Manager • Facilitate communication among investigative sites, client companies, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets

🎯 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 • Equivalency through a 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 • 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 • Effective interpersonal, organizational, and time management skills • Strong attention to detail • Flexibility and adaptability • Ability to work independently and as part of 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 disclosure of vaccination status or other personal information where required • Ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays • Ability to work in environments with potential exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating temperatures • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Opportunity to work with global pharmaceutical and biotechnology companies • Professional development through varied sponsor and monitoring environments • Collaborative relationships with investigative sites and project teams

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