Clinical Research Associate – FSP

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🔥 38 minutes ago

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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 all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage documentation • 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 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 meetings and identify potential investigators with the client company • Initiate clinical trial sites and make recommendations where warranted • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress reports to the Clinical Team Manager • Update study systems according to agreed conventions • Facilitate communication between investigative sites, the client company, and the 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 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 • 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 • Equivalency through appropriate education, training, and/or 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 • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage risk-based monitoring concepts and processes • Effective oral and written communication with medical personnel • 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 or as part of a team • Solid Microsoft Office knowledge 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 with potential exposure to biological fluids and infectious organisms and use required personal protective equipment

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities • Other benefits and privileges of employment