Clinical Research Associate II - Oncology & Neurology (WA, OR, ID, MT, WY, CO)

Clinical Research Associate II - Oncology & Neurology (WA, OR, ID, MT, WY, CO)

Join Thermo Fisher Scientific as a Clinical Research Associate (Level II) and make an impact at the forefront of innovation. We are seeking experienced CRAs with explicit on-site monitoring experience, preferably in Oncology and/or Neurology therapeutic areas. Candidates must reside in WA, OR, ID, MT, WY, or CO, within 60 miles of a major airport. This role involves up to 80% travel.

About the Role

As a Clinical Research Associate (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure adherence to ICH-GCP guidelines and applicable regulations. You will act as a site processes specialist, ensuring subject rights, well-being, and data reliability. Your responsibilities include ensuring audit readiness and developing collaborative relationships with investigational sites.

Essential Functions:

• Monitors investigator sites using a risk-based monitoring approach, applying root cause analysis and problem-solving skills to identify and resolve site process failures and decrease risks.
• Ensures data accuracy through SDR, SDV, and CRF review, as well as assessment of investigational product.
• Documents observations in reports and letters in a timely manner, escalating deficiencies and issues to clinical management for resolution.
• Maintains contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.
• Ensures effective communication between investigative sites, the client company, and the project team.
• Initiates clinical trial sites and performs trial close-out activities, ensuring all essential documents are complete and in place.
• Conducts on-site file reviews and provides study status tracking and progress update reports.
• Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
• Responds to company, client, and regulatory requirements, audits, and inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets.
• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas for process improvement.

Education and Experience Requirements:

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification, or equivalent.
• 1+ years of experience as an on-site clinical research monitor, or completion of a PPD Drug Development Fellowship.
• Oncology and/or Neurology therapeutic experience is highly preferred.
• Valid driver's license where applicable.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Knowledge, Skills and Abilities:

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking, root cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Good oral and written communication skills.
• Effective organizational and time management skills.
• Attention to detail and flexibility.
• Ability to work independently or as part of a team.
• Good computer skills, including Microsoft Office proficiency.

Working Conditions and Environment:

Work is performed in an office/laboratory/clinical/and/or home office environment. Involves frequent drives to site locations and travel (60-80%). May include extended overnight stays. Exposure to biological fluids and office equipment. Personal protective equipment may be required.

Compensation and Benefits:

This is a salaried role eligible for a variable annual bonus. The salary range for this position, based in Oregon, is $66,800.00–$125,000.00. Thermo Fisher Scientific offers a comprehensive Total Rewards package including medical, dental, and vision plans, wellness programs, retirement savings plans (401(k)), paid time off (PTO), paid holidays, parental leave, and other benefits.

Key skills/competency

• Clinical Research Associate
• Oncology
• Neurology
• Clinical Monitoring
• ICH-GCP
• Risk-Based Monitoring
• Site Management
• Regulatory Compliance
• Data Accuracy
• Investigational Sites