Senior Clinical Research Associate I – Multiple Therapies

🕒 5 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $105k - $112k / 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

• 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 inventory and records • Document observations in reports and letters • 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 payment processes and investigator meetings • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform required report quality-control checks • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout, retrieval of trial materials, and completion of essential documents • Conduct on-site file reviews • Contribute to project publications, tools, process improvements, and other assigned project work • Facilitate communication among investigative sites, the client company, and project teams • 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 • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 3+ years • Oncology experience preferred • Strong critical thinking and problem-solving skills • Excellent clinical trials monitoring skills, both remote and on-site • Demonstrated understanding of ICH-GCP guidelines, applicable regulations and SOPs • Strong communication and collaboration skills • Advanced written and oral communication skills • Strong organizational skills and attention to detail • Demonstrated use of computer systems including CTMS and other trial management platforms • Ability to travel >75% as required for site monitoring activities

🏖️ 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 in accordance with company policy • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discount

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