Clinical Research Associate II/Senior – Oncology

🔥 1 minute ago

🌲 Oregon – Remote

🌲 Oregon – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 and onsite monitoring visits to assess regulatory compliance and manage required documentation • Ensure trials follow approved protocols, ICH GCP guidelines, applicable regulations and SOPs • Maintain 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 case report form 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 approved monitoring plans • Participate in investigator payment processes and share responsibility for issue resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform quality-control checks of CTMS reports • Participate in investigator meetings and identify potential investigators with client companies • Initiate clinical trial sites and make recommendations regarding site compliance • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct onsite file reviews • Assist with project publications, tools, trip report reviews, newsletters and CRA team calls • Facilitate communication among investigative sites, client companies and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete administrative tasks such as expense reports and timesheets • Contribute to process improvement initiatives and other project work

🎯 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) • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated 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 with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information • Willingness and ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home office environments • Ability to use required personal protective equipment, including protective eyewear, garments and gloves

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule