Clinical Research Associate I

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🔥 3 hours ago

🏄 California, Colorado, +2 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🌽 Illinois – Remote 🌲 North Carolina – Remote

💵 $75k - $89k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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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 clinical monitoring and site management activities • 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 CRF review during on-site and remote monitoring • 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 to confirm protocol compliance, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Help identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and regulations • Conduct on-site file reviews • Provide trial status tracking and progress reports • Maintain complete and accurate study systems, including Clinical Trial Management Systems • Facilitate communication between sites, the client company, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Assist with project publications, tools, process improvements, and other project initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimal clinical monitoring experience comparable to 2 years in a clinical environment • Experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy may be considered • Valid driver's license where applicable • Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening • Candidates ideally live within 60 miles of a major airport hub • Basic medical/therapeutic area knowledge and medical terminology • Ability to attain and maintain knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills with medical personnel • Good interpersonal, organizational, and time management skills • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage risk-based monitoring concepts and processes • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Frequent travel, generally 60-80%, potentially including extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to use personal protective equipment and work around biological fluids and potentially infectious organisms

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • Choice of 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 • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with company stock available at a discount