Clinical Research Associate II, Senior CRA I – Oncology, Respiratory, Cardiovascular

🔥 3 hours ago

🌲 Oregon – Remote

🌲 Oregon – Remote

💵 $72k - $120k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct remote or onsite monitoring visits to assess regulatory compliance and manage required documentation • Ensure trials follow approved protocols, ICH GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop collaborative relationships with investigator sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions • 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 to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Conduct monitoring tasks according to the approved monitoring plan • Participate in the investigator payment process • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including the Clinical Trial Management System, and perform CTMS report quality checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications and tools and perform additional study tasks assigned by the CTM • 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 • Contribute to process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nurse Certification or equivalent and relevant formal academic/vocational qualification • Minimum of 1 year of oncology monitoring experience, OR minimum of 2 years of standard monitoring experience with relevant prior clinical experience (e.g., MD, RN, Study Coordinator) • Therapeutic area experience preferred in Oncology, Respiratory (COPD, asthma, nasal polyps, etc.) and Cardiovascular • Valid driver's license where applicable • Must live within 60 miles of the nearest major airport • Willingness to travel 60–80% • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including a drug screening • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application 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 skills • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • National medical and dental plans • National vision plan, including health incentive programs • Employee assistance and family support programs • Commuter benefits • Tuition reimbursement • At least 120 hours paid time off (PTO) • 10 paid holidays annually • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) • Accident and life insurance • Short- and long-term disability • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with discounted company stock purchase opportunity

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