Clinical Research Associate II/Senior CRA – Multiple Therapeutic Areas

🕒 July 21

🌽 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.

👻 Ghost score 20%

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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 collaborative relationships with investigational sites • 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 SDR, SDV, and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters • Escalate deficiencies and track issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the monitoring plan • Participate in investigator payments and investigator meetings • Identify potential investigators and initiate qualified clinical trial sites • Perform trial closeout and retrieval of 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 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 project publications, tools, process improvements, and other project 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, 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 • Equivalency combining appropriate education, training, and/or directly related experience may be considered • 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 • Computer skills, including Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and 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 in accordance with company policy • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discount • Fully remote work arrangement