Experienced CRA II/Sr CRA – Multiple Therapeutic Areas

🔥 3 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $135k / year

⏰ Full Time

🟠 Senior

🧪 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 clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor or monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability and audit readiness • 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 data review, source data verification, and CRF review • Assess investigational product through inventory and records review • Prepare monitoring reports and letters and escalate deficiencies and issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • Facilitate communication among investigative 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 and tools and contribute ideas • Contribute to project work 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 • Valid driver's license where applicable • Equivalency of appropriate education, training, and/or directly related experience may be considered • 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 • Customer focus, listening skills, attention to detail, and ability to perceive underlying issues • Organizational and time management skills • Effective interpersonal skills • 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 • Frequent travel availability, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to use personal protective equipment and work with potential exposure to biological fluids and infectious organisms

🏖️ 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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