FSP CRA I/II

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🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

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This company has sponsored H1B visas in the past.

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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 • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Protect subjects' rights and well-being and ensure data reliability • 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 process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator payment processes and investigator meetings • Engage daily with sponsor staff and complementary workers • Initiate, manage and close out clinical trial sites in collaboration with the client • Retrieve trial materials and ensure essential documents are complete and compliant • Conduct on-site file reviews • 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 and timesheets • Assist with project publications and tools • Contribute to project initiatives and process improvements

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Valid driver's license where applicable • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills, including communication with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, with possible extended overnight stays • Ability to work in environments involving potential exposure to biological fluids and infectious organisms • 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 involvement in clinical trials across diverse countries and therapeutic areas • Travel-related experience, including site visits and investigator meetings

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