FSP CRA I/II, Gen Med, Respiratory, HIV, Oncology

🔥 14 hours ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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 for one specific sponsor • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation and ensure audit readiness • Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem solving • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product through physical inventory and records review • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Engage daily with sponsor staff and complementary workers • Collaborate with the client company to qualify and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews according to project specifications • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • 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 • Assist with project publications and tools and contribute ideas to the project team • Contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience providing knowledge, skills, and abilities comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Therapeutic area knowledge in Respiratory, HIV, and Oncology; Respiratory and HIV preferred • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Risk-Based Monitoring concepts and processes • Critical thinking, root cause analysis, and problem-solving skills • Good oral and written communication skills • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time management skills • Interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Presentation skills • Ability to work in office, laboratory, clinical, and/or home-office environments • Ability to travel frequently and drive to site locations • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule • Opportunity to work with global pharmaceutical and biotechnology companies • Frequent travel generally 60–80%, including potential extended overnight stays

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