Senior CRA – Level I

🕒 5 days ago

🇨🇴 Colombia – 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 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 or monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure subject rights, well-being, data reliability, and audit readiness • Develop 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 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 and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes • Provide trial-status tracking and progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform required report quality-control checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and in place • Conduct on-site file reviews • Assist with project publications and tools and contribute ideas • Perform additional study tasks assigned by the CTM, such as trip-report review, newsletter creation, and leading CRA team calls • Facilitate communication between investigative sites, the client company, and the project team • Respond to company, client, 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 and relevant formal academic/vocational qualification • Minimum of 3 years of completed on-site clinical monitoring experience • Minimum of 1.5 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology clinical trials • 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 with medical personnel • Customer focus, listening skills, attention to detail, and ability to perceive underlying issues • Effective 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 • Good English language and grammar skills • Good presentation skills • Ability to comply with specific sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments and use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with global pharmaceutical and biotechnology companies • Frequent travel expenses may be covered (not explicitly stated) • Personal protective equipment provided/required as applicable

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