Clinical Research Associate II – Sponsor-Dedicated FSP

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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

• Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and implement 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 and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow up on issues • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and issue resolution • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems according to agreed conventions • 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 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 • At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalent combinations of education, training, and directly related experience may be considered • Proven clinical monitoring skills • Knowledge of medical/therapeutic areas and medical terminology • Working knowledge of ICH-GCP, applicable regulations, and procedural documents • Critical thinking, root cause analysis, investigation, and problem-solving skills • Ability to manage risk-based monitoring concepts and processes • Good oral and written communication skills • Customer focus, listening skills, and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Solid knowledge of Microsoft Office 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Exposure to rewarding career opportunities and professional development through work supporting life sciences, diagnostics, and therapies • Reasonable accommodation for individuals with disabilities • Equal employment opportunity