Senior Clinical Research Associate

🔥 0 minutes ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $90k - $113k / 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 for a dedicated client • 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 SDR, SDV, and CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters using approved business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain regular contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Track trial status and provide progress updates to the Clinical Trial Manager • Update study systems, including CTMS, and perform required CTMS report quality checks • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout, retrieval of materials, and completion of essential documents • Conduct on-site file reviews • Contribute to project publications, tools, process improvements, and other assigned study tasks • Facilitate communication among investigative sites, the client company, and project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 3+ years of comparable experience • Oncology experience preferred • Strong critical thinking and problem-solving skills • Excellent remote and on-site clinical trials monitoring skills • Understanding of ICH-GCP guidelines, applicable regulations and SOPs • Ability to evaluate data and resolve diverse problems • Good judgement in selecting methods and techniques for solutions • Strong communication and collaboration skills • Ability to interact effectively with investigative sites, clients, and internal teams • Ability to represent the client while maintaining professional relationships • Advanced written and oral communication skills • Strong organizational skills and attention to detail • Experience with computer systems including CTMS and other trial management platforms • Ability to travel >75% for site monitoring activities

🏖️ 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 • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with opportunity to purchase company stock at a discount

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