Senior Clinical Research Associate – FSP

🕒 October 19

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 and guidelines across FSO, FSP, Government, and other monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability and audit readiness • Develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving • Ensure data accuracy through source data review, source data verification, and CRF review • Assess investigational products through physical inventory and records review • Document observations in timely reports and letters; escalate deficiencies and follow issues through resolution • Maintain contact with sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording • 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 study systems, including CTMS, and perform required quality-control checks of CTMS reports • Participate in investigator meetings and identify potential qualified investigators with client collaboration • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications and tools, share ideas, and perform additional study tasks assigned by the CTM • 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 Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimum 3 years of completed on-site clinical monitoring experience • Minimum 2 years of completed experience as lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials • Effective clinical monitoring skills • Medical/therapeutic area knowledge and medical terminology • Understanding and 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 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 comply with sponsor, client, and site requirements, including possible vaccination-status or other personal-information disclosures • Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

🏖️ Benefits

• Frequent travel generally 60–80%, with travel expenses implied by required expense-report administration • Full-time employment • Fully remote work arrangement

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