Clinical Research Associate, Level II/Senior

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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 and manage documentation • Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and case report form review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and 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, including Clinical Trial Management Systems • 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 • Support project publications, tools, process improvements, and other project initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, Registered Nursing certification, or equivalent relevant 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 • Understanding of medical/therapeutic areas and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Risk-Based Monitoring knowledge • Root cause analysis and problem-solving skills • Good oral and written communication skills • Customer focus, listening skills, and attention to detail • Organizational and time management skills • 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 • Willingness and ability to travel frequently, generally 60–80%, including possible overnight stays • Ability to work in environments with potential exposure to biological fluids and infectious organisms, using required personal protective equipment