Clinical Research Associate II/Sr CRA, Multiple Therapeutic Areas

🔥 13 hours 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

🦅 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 on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures, guidelines, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis 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 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 the approved monitoring plan • Participate in investigator payments and investigator meetings • Identify and initiate qualified clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status and progress reports to the Clinical Team Manager • Update clinical trial management systems • Facilitate communication between sites, the client company, and the PPD project team • Respond to company, client, and regulatory audits and inspections • Complete expense reports and timesheets • Assist with 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 a drug screening • Bachelor's degree in a life sciences related field, 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 • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Organizational and time management skills • Effective interpersonal skills and attention to detail • Ability to remain flexible and adaptable • Ability to work independently or in a team • 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 • 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 discount