Senior CRA – FSP

🕒 5 days ago

🇲🇽 Mexico – 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 or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures and guidelines • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure subjects’ rights, well-being and 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 data review, source data verification and CRF review • Assess investigational product through inventory and records review • Prepare monitoring reports and letters; escalate deficiencies 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 and issue/finding resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform report quality-control checks where required • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial close-out and retrieval of trial materials • Ensure essential documents are complete and properly filed • Conduct on-site file reviews • Assist with project publications, tools, newsletters, trip report reviews and CRA team calls • 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 process-improvement initiatives and other project work

🎯 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 • Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology 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 and attention to detail • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficient knowledge of 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 disclosure of vaccination status or other personal information • Ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home-office environments • Ability to use required personal protective equipment when exposed to biological fluids or infectious organisms

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with global clinical research teams and leading pharmaceutical and biotech companies • Professional involvement in clinical trials across diverse sponsors and monitoring environments • Collaborative relationships with investigational sites and project teams

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