Clinical Research Associate, CRA II/SR CRA I/SR CRA II

🔥 16 minutes ago

🌵 Arizona, California, +9 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🥔 Idaho – Remote 🦬 Montana – Remote 🎰 Nevada – Remote 🌶️ New Mexico – Remote 🌲 Oregon – Remote ⛷️ Utah – Remote ☕ Washington – Remote 🦬 Wyoming – Remote

💵 $84k - $120k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 0%

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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

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct remote and onsite 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 • Protect subjects' rights and well-being and ensure data reliability • Maintain audit readiness and collaborative relationships with investigational sites • Apply risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with sites between monitoring visits • Participate in investigator meetings and identify and initiate qualified investigator sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct onsite file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical trial management systems • Facilitate communication among sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications, tools and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship • Equivalency combining appropriate education, training and/or directly related experience may be considered • Valid driver's license where applicable • 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 • Good organizational and time management skills • Effective interpersonal skills and attention to detail • Flexibility and adaptability • Ability to work independently and in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Candidates must be located in AZ, CA, CO, ID, MT, NM, NV, OR, UT, WA or WY • Up to 75% regional travel and frequent onsite visits across the US

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

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