Senior Clinical Research Associate I

🔥 14 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $90k - $113k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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 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 the investigator payment process • Investigate and follow up on findings • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including CTMS, according to study conventions • Perform QC checks of CTMS-generated reports when required • Participate in investigator meetings • Identify potential investigators and qualified investigative sites with the client • Initiate clinical trial sites in compliance with protocol, regulatory, and ICH-GCP obligations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and in place • Conduct on-site file reviews • Contribute to project publications, tools, process improvements, and team initiatives • Perform additional study tasks assigned by the CTM • 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 previous experience providing the knowledge, skills, and abilities to perform the job • 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 • 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 opportunity to purchase company stock at a discount

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