Clinical Research Associate II/Senior Clinical Research Associate – Multiple Therapeutic Areas

🔥 7 minutes ago

🌽 Illinois, Ohio, +3 more states – Remote

🌽 Illinois – Remote 🏈 Ohio – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🧀 Wisconsin – Remote

💵 $66.8k - $125k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 • Manage required documentation, sponsor procedures, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Ensure audit readiness and develop relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis, and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters • Escalate deficiencies and follow issues 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 such as Clinical Trial Management Systems • Facilitate communication among 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 project publications, tools, process improvements, and other initiatives

🎯 Requirements

• 1–2 years of traveling on-site monitoring experience • Therapeutic experience in at least one of: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary • Must live within 60 miles of the nearest major airport • Up to 80% travel expected • Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening • Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification • Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Risk-Based Monitoring concepts and processes • Root cause analysis and problem-solving skills • Good oral and written communication skills • Organizational and time management skills • Microsoft Office proficiency 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 • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with company stock available at a discount • Fully remote work arrangement • Home office environment option

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